TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

K072714 · Roche Diagnostics Corp. · LCP · Apr 18, 2008 · Hematology

Device Facts

• Record ID: K072714
• Device Name: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LCP · Hematology
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Tina-Quant Hemoglobin A1c Gen.2 test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of percent hemoglobin A1c in hemolysate or whole blood. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Story

Tina-Quant Hemoglobin A1c Gen.2 Test System; in vitro diagnostic assay for quantitative HbA1c measurement in human whole blood. Modification extends measuring range from 0.3-2.6 g/dL to 0.3-3.4 g/dL HbA1c. Utilizes immunoturbidimetric principle; automated analysis on Roche clinical chemistry analyzers. Used in clinical laboratory settings by trained personnel. Output provides HbA1c concentration for monitoring glycemic control in patients with diabetes. Modification includes validation for potassium fluoride/Na2-EDTA anticoagulant use.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm performance within the extended measuring range (0.3-3.4 g/dL) and compatibility with potassium fluoride/Na2-EDTA anticoagulant.

Technological Characteristics

Turbidimetric inhibition immunoassay (TINIA). Reagents: R1 (MES/TRIS buffer, sheep anti-HbA1c antibody), R2 (polyhapten modified with aminodextran). Bichromatic photometric detection. Compatible with Roche Integra/cobas clinical chemistry analyzers. Automated on-board sample pretreatment. Measuring range 0.3-3.4 g/dL HbA1c (Integra 800/800 CTS).

Indications for Use

Indicated for the quantitative determination of percent hemoglobin A1c in whole blood or hemolysate derived from whole blood on Roche clinical chemistry analyzers to monitor long-term blood glucose control in individuals with diabetes mellitus.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• Tina-Quant Hemoglobin A1c Gen.2 Test System (K052464)

Submission Summary (Full Text)

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K072714

APR 1 8 2008

## 510(k) Summary – Tina-Quant® Hemoglobin A1c Gen.2

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 9115 Hague Rd Indianapolis IN 46250 [phone]

Contact person: Tracy Bush

Oct 15, 2007 Date prepared:

Submission Purpose and History

The Tina-Quant Hemoglobin A 1c Gen.2 assay was originally cleared for use as K052464. The purpose of this submission is to modify the device by extending the labeled measuring range for the HbA Ic portion of the %HbAlc measurement in the application for Integra 800 analyzers.

Since the clearance of K052464, a number of changes have taken place to the device, for which an additional filing was not deemed necessary. We hereby provide notification of these changes:

- . Inclusion of additional anticoagulant type (potassium fluoride/ Na2-EDTA) in the Specimen Collection and Preparation section of the labeling (supported via internally documented data)
Device Name

Proprictary name: Tina-Quant® Hemoglobin A1c Gen.2 test

Common name: Hemoglobin A1c test

Classification name: Glycosylated hemoglobin assay

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| Device<br>Description | With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated<br>whole blood specimen is hemolyzed prior to determination of HbA1c by an<br>turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb)<br>in the hemolyzed sample is converted to a derivative having a characteristic<br>absorption spectrum and measured bichromatically. The instrument<br>calculates the % HbA1c from the HbA1c/ Hb ratio according to a user<br>selected protocol. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Tina-Quant Hemoglobin A1c Gen.2 test is in vitro diagnostic reagent<br>system intended for use on the COBAS INTEGRA 800 analyzers for the<br>quantitative determination of percent hemoglobin A1c in hemolysate or<br>whole blood. HbA1c determinations are useful for monitoring of long-term<br>blood glucose control in individuals with diabetes mellitus. |
| Predicate<br>Device | We claim substantial equivalence to the Tina-Quant ® Hemoglobin A1c<br>Gen.2 cleared as K052464. |
| Substantial<br>equivalency –<br>Similarities | The table below indicates the similarities between the modified Tina-Quant ®<br>Hemoglobin A1c Gen.2 test and its predicate device (original Tina-Quant®<br>Hemoglobin A1c Gen.2, K052464). |

:

| Feature | Predicate: Tina-Quant ®<br>Hemoglobin A1c Gen.2 (K052464) | Modified device: Tina-Quant<br>HbA1c Gen.2 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/<br>Indications for<br>Use | For the quantitative determination of<br>percent hemoglobin A1c in whole<br>blood (or hemolysate derived from<br>whole blood) on COBAS Integra<br>800 anlayzers. HbA1c<br>determinations are useful for<br>monitoring of long-term blood<br>glucose control in individuals with<br>diabetes mellitus. | For the quantitative determination<br>of percent hemoglobin A1c in<br>whole blood (or hemolysate derived<br>from whole blood) on Roche<br>clinical chemistry analyzers. |
| Indications for<br>Use | HbA1c determinations are useful for<br>monitoring of long-term blood<br>glucose control in individuals with<br>diabetes mellitus. | HbA1c determinations are useful<br>for monitoring of long-term blood<br>glucose control in individuals with<br>diabetes mellitus. |

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| Specimen type | Anticoagulated venous or capillary<br>blood. Acceptable anticoagulants in<br>clude Li-heparin, K2-EDTA, K3-<br>EDTA | Anticoagulated venous or capillary<br>blood. Acceptable anticoagulants in<br>clude Li-heparin, K2-EDTA, K3-<br>EDTA and potassium fluoride/Na2-<br>EDTA |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument<br>platform | Integra 800 analyzer | Integra family including Integra<br>400/400 plus, 800, 800 CTS<br>(Closed Tube Sampling), cobas<br>c111; also cobas c501 |
| Test principle | | |
| Determination of<br>HbA1c | Turbidimetric immunoinhibition<br>(TINIA). Antigen-antibody<br>complexes are formed and excess<br>Ab aggregate with polyhapten to<br>form insoluble complexes. | Same |
| Determination of<br>Hb | Bichromatic photometric<br>determination after conversion to a<br>colored derivative.<br>Hb is measured in same channel<br>during preincubation phase of<br>HbA1c determination (sample +<br>R1). | Same. |
| Calculation of %<br>HbA1c | % HbA1c is calculated<br>automatically by instrument<br>according to user-selected protocol | Same |
| Pretreatment | Two options for pretreatment:<br><br>Hemolysate application:<br>same (Manual pretreatment with<br>hemolyzing reagent)<br><br>Whole blood application:<br>automated on-board sample<br>pretreatment with hemolyzing<br>reagent | Same |
| Reagent information | | |
| Antibody | Polyclonal anti-HbA1c from sheep<br>blood | Same. |
| Calibrator | Hemolysate derived from human<br>blood and sheep blood; TTAB<br>detergent; stabilizer. | Same |
| Quality control | Precinorm HbA1c<br>Precipath HbA1c | Same |
| R1 | Buffer: 25 mM MES/ 15 mM TRIS<br>pH 6.2<br>Antibody; stabilizers | Same |
| R2 | Buffer: 25 mM MES/15mM Tris, ph 6.2;<br>Polyhapten modified with<br>aminodextran AD500; concentration<br>> 8ug/mL; Stabilizers | Same |
| Hemolyzing<br>reagent | Different concentrations used | Same |
| | Hemolysate application:<br>Uses separate hemolyzing reagent<br>with 20 mM EDTA | |
| | Whole blood application:<br>Uses Hemolyzing reagent Gen.2 –<br>fourfold increase in concentration | |
| Reagent stability | 2-8 °C until expiration date<br>On-board: 28 days | Same |
| Performance characteristics (Integra) | | |
| Precision | Whole blood application:<br>Within run:<br>0.8% @ 5.4% HbA1c<br>0.9% @ 10.2% HbA1c | Same |
| | Between day:<br>1.3% @ 5.3% HbA1c<br>1.0% @ 10.3% HbA1c | |
| | Hemolysate application<br>Within run:<br>1.0% @ 5.5% HbA1c<br>0.6% @ 10.6% HbA1c | |
| | Between day:<br>1.0% @ 5.3% HbA1c<br>0.8% @ 10.7% HbA1c | |
| | | |
| Lower detection<br>limit | 0.02 g/dL HbA1c<br>0.09 g/dL Hb | Same |
| Endogenous<br>interferences | Whole blood application:<br>No significant interference from:<br>Icterus | Same |
| | Lipemia: up to 800 mg/dL Intralipid | |
| | Rheumatoid factor: up to 750 IU/mL | |
| | Glycemia: up to 1000 mg/dL glucose | |
| | | |
| Expected values | 2.9-4.2% HbA1c<br>Based on study done with IFCC<br>standardization | Same |
| Specificity | No cross reaction with HbAo,<br>HbAla, HbA1b, acetylated<br>hemoglobin, carbamylated<br>hemoglobin, glycated albumin and<br>labile HbA1c were found for the<br>anti-HbA1c antibodies used in this<br>kit.<br>Specimens containing high amounts<br>of HbF (>10%) may yield lower than<br>expected HbA1c results. | Same |

and the control control of the control of

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Substantial The table below indicates the differences between the modified Tina-Quant ® equivalency --Hemoglobin A 1c Gen.2 test and its predicate device (original Tina-Quant ® Differences Hemoglobin A1c Gen.2, K052464).

| Feature | Predicate: Tina-Quant ®<br>Hemoglobin A1c Gen.2 (K052464) | Modified device: Tina-Quant<br>HbA1c Gen.2 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Specimen type | Anticoagulated venous or capillary<br>blood. Acceptable anticoagulants in<br>clude Li-heparin, K2-EDTA, K3-<br>EDTA | Anticoagulated venous or capillary<br>blood. Acceptable anticoagulants in<br>clude Li-heparin, K2-EDTA, K3-<br>EDTA and potassium fluoride/Na2-<br>EDTA |
| Instrument<br>platform | Integra 800 analyzer | Integra family including Integra<br>400/400 plus, 800, 800 CTS<br>(Closed Tube Sampling), cobas<br>c111; also cobas c501 |
| Performance Characteristics (Integra) | | |
| Measuring<br>Range | 0.3-2.6 g/dL HbAlc*<br>4-35 g/dL Hb<br>*Based on concentration of the<br>highest standard | Integra 400/400 plus:<br>same<br>Integra 800/ 800 CTS:<br>0.3 - 3.4 g/dL HbA1c<br>4-35 g/dL Hb |

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| Endogenous interferences<br>(whole blood application<br>only) | Analyte recovery in presence<br>of interfering agent. Tested<br>for:<br>Lipemia (Intralipid) Bilirubin (conjugated<br>and unconjugated) Rheumatoid Factor Glucose | No significant interference<br>(bias within ± 10%) up to:<br>800 mg/dL Intralipid 30 mg/dL Bilirubin/<br>ditaurobilirubin 350 IU/mL RF 1000 mg/dL Glucose |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anticoagulant | Testing of ≥ 50 paired samples<br>(i.e. serum/plasma) | Both reagent-specific and<br>general criteria apply<br>(based on NGSP values)<br>Reagent-specific criteria Mean deviation of all<br>samples: <= 0.2% HbA1c Maximum deviation of<br>single sample: <= 0.75%<br>HbA1c General criteria for unlimited<br>acceptance of anticoagulant<br>type: Median deviation of<br>recovery against reference<br>for all sample pairs <= 5%<br>recovery Maximum deviation of<br>recovery of 80% of all<br>sample pairs <= 10%<br>recovery ( up to 20% of<br>samples can be within 10-<br>15% recovery vs reference) |
| Specificity | Testing not required provided<br>antibody does not change and<br>reagent/sample ratio remains<br>similar | Specificity claims transferred<br>from predicate Tina-Quant<br>HbA1c device |

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Theresa A. Bush, Ph.D. Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250

## APR 1 8 2008

Re: k072714

Trade/Device Name: Tina-Quant® Hemoglobin A1c Gen.2 Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay. Regulatory Class: Class II Product Code: LCP Dated: March 19, 2008 Received: March 20, 2008

Dear Dr. Bush:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., 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

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## Indications for Use

510(k) Number (if known):

Device Name: Tina-Quant® Hemoglobin A1c Gen.2 Test System

Indication For Use:

For the quantitative determination of percent hemoglobin Alc in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers.

HbAlc determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Prescription Use XXX (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)

Carol Benson

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

510(k) K072714