TINA-QUANT ALBUMIN GEN.2

K113072 · Roche Diagnostics Operations · DCF · May 14, 2012 · Immunology

Device Facts

• Record ID: K113072
• Device Name: TINA-QUANT ALBUMIN GEN.2
• Applicant: Roche Diagnostics Operations
• Product Code: DCF · Immunology
• Decision Date: May 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Device Story

In vitro diagnostic assay; utilizes immunoturbidimetric principle; anti-albumin antibodies react with albumin in human urine samples to form antigen/antibody complexes; agglutination measured turbidimetrically; performed on Roche/Hitachi cobas c 311 analyzers; operated by laboratory personnel; output provides quantitative albumin concentration; aids clinicians in diagnosing kidney and intestinal diseases.

Clinical Evidence

Bench testing only. Precision evaluated over 21 days (n=84/sample) with CVs < 3%. Linearity validated per CLSI EP6-A (slope 0.97, r=0.998). Analytical specificity tested against endogenous interferents (bilirubin, hemoglobin) and common drugs; no interference observed. Method comparison with predicate (n=69) showed good correlation (r=0.972, y=1.04x-0.42).

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-albumin antibodies; reagent stability 12 weeks at 2-8°C; measuring range 12-200 mg/L; automated analysis on Roche/Hitachi cobas c 311 platform; includes prozone check for high-dose hook effect up to 40,000 mg/L.

Indications for Use

Indicated for quantitative determination of albumin in urine to aid in diagnosis of kidney and intestinal diseases. For prescription use only.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• Tina-quant Albumin Gen.2 - cobas c 501 urine assay (K101203)

Submission Summary (Full Text)

{0}------------------------------------------------

K11.3072

:

Tina-quant Albumin Gen. 2 Assay

## 510(k) Summary

MAY 1 4 2012

:

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>Phone: (317) 521 - 3954<br>Fax: (317) 521 - 2324<br>Contact Person: Patrick Stimart<br>Date Prepared: October 4, 2011 |
| Device Name | Proprietary names: Tina-Quant Albumin Gen. 2<br>Common names: Albumin Gen. 2 - cobas c 311 urine assay<br>Regulation: 21 CFR 866.5040<br>Classification names: Albumin Immunological Test System<br>Product codes: DCF |
| Device Description | The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically. |
| Intended use | Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine on the Roche/Hitachi cobas c 311 analyzers. |
| Indications for Use | The Tina-quant Albumin Gen. 2- cobas c 311 urine assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in urine on the Roche/Hitachi cobas c 311analyzers. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. |

{1}------------------------------------------------

Tina-quant Albumin Gen. 2 Assay

Substantial equivalence

The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay is substantially equivalent to the Tina-quant Albumin Gen.2 - cobas c 501 urine assay. The cobas c 501 Tina-quant Albumin Gen. 2 assay was cleared under K101203.

| Substantial<br>equivalence -<br>comparison | | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Tina-quant Albumin Gen. 2 - cobas<br>c 311 urine Assay | Tina-quant Albumin Gen. 2 -<br>cobas c 501 urine Assay<br>Predicate device - K101203 |
| Intended Use | For cobas c 311: In vitro test for the<br>quantitative determination of albumin<br>in human urine. | In vitro test for the quantitative<br>determination of albumin in human<br>urine, serum, plasma and CSF on<br>Roche/Hitachi cobas c systems. |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Urine | Same |
| Labeled<br>Instrument<br>Platform | Roche/Hitachi cobas c systems -<br>cobas c 311 | Roche/Hitachi cobas c systems -<br>cobas c 501 |
| Calibrator | C.f.a.s. PUC | Same |
| Calibration<br>Frequency | - after reagent lot change<br>- as required following quality control<br>procedures | Same |
| Controls | Urine<br>Precinorm PUC and Precipath PUC<br>In addition, other suitable control<br>material can be used. | Same |
| Reagent<br>Stability | On-board in use: 12 weeks at 2-8° C | Same |
| Measuring<br>Range | 12-200 mg/L | 12-400 mg/L |
| Precision | Repeatability (Within-run) (mg/L):<br>Mean = 32.0, SD = 0.2, CV = 0.7%<br>Mean = 101, SD = 1, CV = 1.2%<br>Mean = 10.7, SD = 0.2, CV = 2.2%<br>Mean = 132, SD = 2, CV = 1.9% | Repeatability (Within-run) (mg/L):<br>Mean = 30.7, SD = 0.2, CV = 0.8%<br>Mean = 108, SD = 1, CV = 0.7%<br>Mean = 14.3, SD = 0.2, CV = 1.6%<br>Mean = 252, SD = 4, CV = 1.6% |
| | Intermediate Precision (Total) (mg/L):<br>Mean = 31.3, SD = 0.6, CV = 1.9%<br>Mean = 97.9, SD = 0.7, CV = 0.7%<br>Mean = 13.6, SD = 0.4, CV = 2.9%<br>Mean = 63.7, SD = 0.7, CV = 1.1% | Intermediate Precision (Total) (mg/L):<br>Mean = 31.2, SD = 0.5, CV = 1.7%<br>Mean = 105, SD = 1, CV = 1.2%<br>Mean = 13.6, SD = 0.4, CV = 2.8%<br>Mean = 60.6, SD = 1.4, CV = 2.3% |
| Analytical<br>Sensitivity | Limit of Blank (LoB) =2 mg/L<br>Limit of Detection (LoD) =3 mg/L<br>Limit of Quantitation (LoQ) =12 mg/L | Same |
| Analytical<br>Specificity | No interference was found at<br>therapeutic concentrations using<br>common drug panels.<br>High dose hook-effect: Using the<br>prozone check, no false result<br>without a flag was observed up to an<br>albumin concentration of 40000 mg/L | Same |
| Interferences | Criterion: Recovery within ± 10%<br>Icterus: no significant interference up to<br>a conjugated bilirubin concentration of 50<br>mg/dL.<br>Hemolysis: No significant interference<br>up to a hemoglobin concentration of 400<br>mg/dL.<br>No interference by acetone ≤ 60 mmol/L,<br>ammonia chloride ≤0.11 mol/L, calcium<br>≤40 mmol/L, Creatinine ≤0.18 mol/L, y-<br>globulin ≤500 mg/L, glucose ≤0.19<br>mol/L, urea ≤0.8 mol/L, uric acid ≤5.95<br>mmol/L and urobilinogen ≤378 umol/L. | Same |
| Expected | 2nd morning urine: | Same |
| Values | Adults:<br><20 mg albumin/g creatinine or <2.26 g albumin/mol creatinine | |
| | Children (3-5 years):<br><20 mg/L albumin<br><37 mg albumin/g creatinine | |
| | 24 hour urine:<br><20 mg/L<br><30 mg/24 h | |
| Method<br>Comparisons | A comparison of the Roche Tina-quant Albumin Gen. 2 assay on the c 501<br>analyzer (K101203) (x) with the Roche Tina-quant Albumin Gen. 2 assay on<br>the c 311 analyzer (y) for human urine samples gave the following correlation: | |
| | Passing Bablock<br>$y = 1.036x + 0.415$ mg/L<br>$\tau = 0.972$ | Linear Regression<br>$y = 1.038x - 1.066$ mg/L<br>$r = 0.999$ |
| | n = 69<br>Sample concentrations were between 13.0 and 189.6 mg/L | |

{2}------------------------------------------------

Tina-quant Albumin Gen. 2 Assay

.

.

:

{3}------------------------------------------------

Tina-quant Albumin Gen. 2 Assay

- - - - -

.

:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

End of Document

.

:

. .

{4}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged in a circle around a stylized image of an eagle. The eagle is facing right and has its wings spread. The seal is black and white.

10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Patrick Stimart 9115 Hague Road Indianapolis, IN 46250-0416

MAY 1 4 2012

k113072 Re:

> Trade Name: Tina-quant Albumin Gen.2 Regulation Number: 21 CFR 8866,5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Codes: DCF Dated: March 29, 2012 Received: April 2, 2012

Dear Mr. Stimart:

We have reviewed your Section 510(k) premarket notification of intent to market the device 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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{5}------------------------------------------------

## Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours.

N

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known): k113072

Device Name: Tina-quant Albumin Gen.2

Indications For Use:

The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113072