JA'N .

31 2fl00

510O(k) Summary - C.f.a.s. (Calibrator for Automated

Systems) PUC (Proteins in UrineICSF); Precinorm ® PUC and
Precipath ® PUG

Introduction According to the requirements of 2l CFR 807.92, the following inforniation

provides sufficient detail to understand the basis for a determination of
substantial equivalence

Submitter Roche Diagnostics

name, address, 9115 Hague Rd
contact Indianapolis IN 46250
(31 7) 521-3723

Contact person: Theresa M. Ambrose

Date prepared: January 5, 2005

Device I Name Proprietary name: Roche Diagnostics C~fa~s. (Calibrator for automated
systems) PUC (Proteins in Urine/CSF)

Common name: C.f~a.s. PUC

Classification name: Calibrator, multi-analyte mixture

Device 2 Name Proprietary name: Roche Diagnostics Precinorm ® PUC (Proteins in

Urine/CSF) and Precipath ® PUC (Proteins in Urine/CSF

Common name: Precinorm t PUC / Precipath® PUC

Classification name: Multi-analyte controls, all kinds (assayed and

unassayed)
Continued on next page

27
~~ ~~ ~-¾I, 10S
Ifl(,\ ,b-e, Mnrifirtinn C fa, , Pi IC' Pr~ccnorrn PIKC and Precinath PUC
510(k) Summary, continued
Device I C.fa.s. PAC is a liquid, ready-for-use calibrator consisting of a buffered
description aqueous solution with biological materials added as required to obtain desired
component levels. Values for constituent analytes are provided in the product
labeling.

Device 2 Precinorm ® PUC/ Precipath OR PUC is a liquid ready-for-use control based

description on a buffered aqueous solution. Concentrations of control components have
been adjusted to represent normal and pathological ranges. Values for
constituent analytes are provided in the product labeling.

Device I C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on
Intended use Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Device 2 Precinorm ®t PUC/ Precipath ® PUC is for use in quality control by

Intended use monitoring accuracy and precision for the quantitative methods as specified in
the enclosed value sheet

Device I For C.f.a.s. PUC, Roche claims substantial equivalence to the currently
Substantial marketed currently marketed C.fa.s. PUC, K040264.
Equivalence

Substantial The table below compares C.fa.s. PUC with its predicate device (currently
equivalence marketed C.f.a.s. PUC, K040264).
comparison -
Device 1

Continued on next page

28
rhe flhienopnicv qrSn~eial SI 0(k' Device Modification C.f a.s. PUC: Precinorm PUC and Precipath PUC
 510(k) Summary, continued

Characteristic C.f.a.s. PUC (Predicate device, C.f.a.s. PUC (Modified Device)

K040264)
Intended Use Cf a.s. PUG is for use in the Same
calibration of quantitative Roche
methods on Roche clinical chemistry
analyzers as specified in the
enclosed value sheet.
Format Liquid ready-for-use calibrator Same
based on a buffered aqueous
solution. The concentrations of the
calibrator components have been
adjusted to ensure optimal
calibration of the appropriate Roche
methods on clinical chemistry
analyzers.
Stability Unopened Same
Stable at 2-8°C until expiration date
Opened:
Stable at 2 to 80C for 4 weeks
Level Single level Same
Constituent · Albumin a Albumin
Analytes with * Total protein * Total protein
Assigned * Immunoglobulin G
Values

Device 2 For Precinorm ® PUC and Precipath ® PUC, Roche claims substantial
Substantial equivalence to the currently marketed Roche Diagnostics Precinorm ® PUC
Equivalence and Precipath ®PUC (K041812).

Substantial The table below compares Precinorm ® PUC / Precipath® PUC with the
Equivalence - predicate device (currently marketed Precinorm ® PUC / Precipath® PUC).
Device
comparison

Continued on next page

29
Rnrhp flP~crnrctiq Sneciaf 510(k) Device Modification C.fa.s. PUC; Precinorm PUC and Precipath PUC
510(k) Summary, continued

Characteristic Precinorm ® PUC / Precipath® Precinorm R)PUC /

PUC (Predicate device, K040264) Precipath® PUC (Modified
Device)
Intended Use For use in quality control by Same
monitoring accuracy and precision
for the quantitative methods as
specified in the enclosed value sheet
Format Liquid ready-for-use control based Same
on a buffered aqueous solution.
Concentrations of control
components have been adjusted to
represent normal and pathological
ranges.
Stability Unopened Same
Stable at 2-8°C until expiration date
Opened:
.. _______ Stable at 2 to 8°C for 4 weeks
Constituent Analytes Precinorm Precinorm
with Assigned Values * Albumin * Albumin
* Creatinine * Creatinine
* Total Protein * Total Protein
* Immunoglobulin G
Precipath
* Albumin Precipath
* Creatinine * Albumin
* Total Protein * Creatinine
* Immunoglobulin A * Total Protein
* Immunoglobulin M · Immunoglobulin A
* Immunoglobulin M
* Immunogobulin G

30
Roche Diagnostics: SDecial 510(k) Device Modification C.fa.s. PUC; Precinorm PUC and Precipath PUC
Note:
Page 31 is a duplicate of Page 30.

510(k) Summary, continued

Characteristic Precinorm ® PUC / Precipath® Precinorm ® PUC /

PUC (Predicate device, K040264) Precipath® PUC (Modified
Device)
Intended Use For use in quality control by Same
monitoring accuracy and precision
for the quantitative methods as
specified in the enclosed value sheet
Format Liquid ready-for-use control based Same
on a buffered aqueous solution.
Concentrations of control
components have been adjusted to
represent normal and pathological
ranges.
Stability Unopened Same
Stable at 2-8°C until expiration date
Opened:
Stable at 2 to 8°C for 4 weeks
Constituent Analytes Precinorm Precinorm
with Assigned Values * Albumin * Albumin
· Creatinine * Creatinine
* Total Protein · Total Protein
* Immunoglobulin G
Precipath
* Albumin Precipath
* Creatinine * Albumin
* Total Protein * Creatinine
* Immunoglobulin A * Total Protein
* Immunoglobulin M · Immunoglobulin A
* Immunoglobulin M
.Immunoglobulin G

31
Roche Diagnostics: Special 510(k) Device Modification C.f£a.s. PUC; Precinorm PUC and Precipath PUC
 DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Druq Administration

2098 Gaither Road
Rockville MD 20850

Theresa M. Ambrose, PhD, RAC JAN 3 1 2005

Regulatory Affairs Principal
Roche Diagnostics
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250

Re: k050026
Trade/Device Name: C.f.a.s (Calibrator for Automated Systems) Proteins in Urine/CSF
(PUC)
Precinorm® Proteins in Urine/CSF (PUC) and Precipath I PUC
Regulation Number: 21 CFR 862.1150
Regulation Name: Calibrator
Regulatory Class: Class IL
Product Code: JIX, JJY
Dated: January 5, 2005
Received: January 6, 2005

Dear Dr. Ambrose:

device
We have reviewed your Section 510(k) premarket notification of intent to market the
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
or to
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments,
Drug,
devices that have been reclassified in accordance with the provisions of the Federal Food,
(PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application
the Act. The
You may, therefore, market the device, subject to the general controls provisions of
of
general controls provisions of the Act include requirements for annual registration, listing
and
devices, good manufacturing practice, labeling, and prohibitions against misbranding
adulteration.
III (PMA),
If your device is classified (see above) into either class II (Special Controls) or class
device
it may be subject to such additional controls. Existing major regulations affecting your
to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800
may publish further announcements concerning your device in the Federal Register.
not mean
-Please be advised that FDA's issuance of a substantial equivalence determination does
of the Act
that FDA has made a determination that your device complies with other requirements
must
or any Federal statutes and regulations administered by other Federal agencies. You
listing (21
comply with all the Act's requirements, including, but not limited to: registration and
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your
device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device,
In
or questions on the promotion and advertising of your device, please contact the Office of
Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the
regulation entitled, "Misbranding by reference to premarket notification (21CFR Part 807.97).
You may obtain other general information on your responsibilities under the Act from the
number
Division of Small Manufacturers, International and Consumer Assistance at its toll-free
(800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industr¥/support/infdex.html

Sincerely yours,

lean M. Cooper, MS, D.V.M.

Director
Division of Chemistry and Toxicology
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health

Enclosure
 Indications for Use

5 1.0(k) Number (if known):

Device Name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® PUC

Indications For Use:

Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy
and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ®
PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision
for the quantitative methods as specified in the enclosed value sheet.

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

'~Ivision Sidn-Oft
Page I of__ 1_
Office cf Ic Vxt-'ie Dki:gnri,
Device Evatuofion on r!

510(k) 7(( J.< 25

25
 Indications for Use

510(k) Number (if known): A 0f'•VO d,1 '

in Urine/CSF (PUC)
Device Name: C.fa.s. (Calibrator for Automated Systems) Proteins
Indications For Use:
on Roche clinical
C.fa.s. PUC is for use in the calibration of quantitative Roche methods
chemistry analyzers as specified in the enclosed value sheet.

AND/OR Over-The-Counter Use

Prescription Use _X _ (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart 1))

ON ANOTHER PAGE IF
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE
NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of-
Off'ce~ of InVitro Diagnostic
Device Evaluation and Safety

24