TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

K052464 · Roche Diagnostics Corp. · LCP · Sep 30, 2005 · Hematology

Device Facts

• Record ID: K052464
• Device Name: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
• Applicant: Roche Diagnostics Corp.
• Product Code: LCP · Hematology
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Tina-Quant Hemoglobin A 1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin Alc in whole blood. HbA1c results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Story

Tina-Quant Hemoglobin A1c Gen.2 is an in vitro diagnostic reagent system for automated analyzers (e.g., Integra 800). It processes anticoagulated whole blood specimens via two application modes: manual hemolysate or automated on-board whole blood pretreatment. The system utilizes a turbidimetric inhibition immunoassay (TINIA) to measure HbA1c; antigen-antibody complexes form, and excess antibody aggregates with polyhapten to create insoluble complexes. Total hemoglobin is measured bichromatically in the same channel during preincubation. The instrument calculates % HbA1c from the HbA1c/Hb ratio. Results assist clinicians in monitoring long-term glycemic control in diabetic patients, providing improved precision and interference resistance compared to the predicate.

Clinical Evidence

Bench testing only. Performance data includes precision (within-run 0.6-1.0%, between-day 0.8-1.3%), linearity (0.3-2.6 g/dL HbA1c), and lower detection limits (0.02 g/dL HbA1c). Interference studies confirmed robustness against icterus, lipemia (up to 800 mg/dL), rheumatoid factor, and glucose. Standardized against IFCC reference method.

Technological Characteristics

In vitro diagnostic reagent system; TINIA principle; bichromatic photometric Hb measurement; automated on-board pretreatment; reagents include MES/TRIS buffers, polyclonal anti-HbA1c (sheep), and aminodextran-modified polyhapten; standardized to IFCC reference method; compatible with automated analyzers (e.g., Integra 800).

Indications for Use

Indicated for the quantitative determination of percent hemoglobin A1c in whole blood 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 (K934070)

Submission Summary (Full Text)

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SEP 3 0 2005

K052464

## 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 |
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| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Theresa M. Ambrose<br>Date prepared: Sept 7, 2005 |
| Device Name | Proprietary name: Tina-Quant® Hemoglobin A1c Gen.2 test |
| | Common name: Hemoglobin A1c test |
| | Classification name: Glycosylated hemoglobin assay |
| Device Description | With the Tina-Quant Hemoglobin A 1 c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA 1c by an turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA lc from the HbA 1c/ Hb ratio according to a user selected protocol. |
| Intended use | The Tina-Quant Hemoglobin A 1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin Alc in whole blood.<br>HbA1c results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus. |
| Predicate Device | We claim substantial equivalence to the Tina-Quant ® Hemoglobin cleared as K934070. |

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The table below indicates the similarities between the modified Tina-Quant ® Substantial equivalency -Hemoglobin A1c Gen.2 test and its predicate device (original Tina-Quant ® Similarities Hemoglobin, K934070).

| Feature | Predicate device: original Tina-<br>Quant HbAlc<br>(K934070) | Modified device: Tina-Quant<br>HbAlc Gen.2 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/<br>Indications for<br>Use | For the quantitative determination of<br>hemoglobin Alc in whole blood.<br><br>From summary: Measurements are<br>useful to provide an indication of<br>glycemic control in patients with<br>diabetes mellitus. | The Tina-Quant Hemoglobin Alc<br>Gen.2 test is an in vitro diagnostic<br>reagent system intended for the<br>quantitative determination of<br>percent hemoglobin Alc in whole<br>blood.<br>HbA1c results are useful for<br>monitoring of long-term blood<br>glucose control in individuals with<br>diabetes mellitus |
| Specimen type | Capillary blood;EDTA or<br>heparinized whole blood. | Same |
| Test principle | | |
| Determination of<br>HbAlc | 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. | Same. |
| Calculation of %<br>HbAlc | % HbAlc is calculated<br>automatically by instrument<br>according to user-selected protocol | Same |
| Reagent information | | |
| Hemolyzing<br>reagent: sample<br>ratio | 1:100 | Same |
| Antibody | Polyclonal anti-HbAlc from sheep<br>blood | Same antibody. |
| Calibrator | Hemolysate derived from human<br>blood and sheep blood; TTAB<br>detergent; stabilizer. | Same |
| Quality control | Precinorm HbAlc<br>Precipath HbAlc | Same |
| Performance characteristics | | |
| Specificity | No cross-reactivity with HbAo, HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, glycated albumin, labile HbA1c and HbA1d and an acetaldehyde hemoglobin adduct. | Stability claims transferred from predicate device due to use of same antibody and similar reagent: sample ratio. |

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The table below indicates the differences between the modified Tina-Quant ® Substantial equivalency -Hemoglobin A 1 c Gen.2 test and its predicate device (original Tina-Quant ® Differences Hemoglobin, K934070).

| Feature | Predicate device: original Tina-<br>Quant HbA1c<br>(K934070) | Modified device: Tina-Quant<br>HbA1c Gen.2 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pretreatment | Manual pretreatment with<br>hemolyzing reagent | 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 |
| Instruments | Automated analyzers including<br>Hitachi family | Integra 800 |
| Determination of<br>Hb | Occurs in separate channel with<br>separate reagent. | Hb is measured in same channel<br>during preincubation phase of<br>HbA1c determination (sample +<br>R1). No separate reagent or channel<br>needed. |
| R1 | Buffer: 50 mM MES, pH6.2<br>Antibody; stabilizers | Buffer: 25 mM MES/ 15 mM TRIS<br>pH 6.2<br>Antibody; stabilizers |
| R2 | Buffer: 50 mM MES, pH 6.2;<br>Polyhapten modified with<br>aminodextran AD50; concentration<br>> 20 ug/mL<br>Stabilizers | Buffer: 25 mM MES/15mM Tris,<br>ph 6.2;<br>Polyhapten modified with<br>aminodextran AD500;<br>concentration > 8ug/mL; Stabilizers |
| Hemolyzing<br>reagent | Contains 10 mM EDTA and TTAB<br>detergent | Different concentrations used |
| | | 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<br>No separate reagent needed. |
| Hb reagent | Phosphate buffer 20 mM, pH 7.4;<br>stabilizers | |
| Calibrator | Provided with kit as lyophilisate in<br>four levels. | Provided separately as single level;<br>diluted on-board the analyzer. |
| Traceability | In-house reference materials | Standardized against approved<br>IFCC reference method |
| Reagent stability | 2-8 °C until expiration date<br>opened: 4 weeks at 2-12 °C | 2-8 °C until expiration date<br>On-board: 28 days |
| Precision | Within run:<br>3.8% @ 5.2% HbA1c<br>4.0% @ 11.3% HbA1c<br><br>Total:<br>5.8% @ 5.2% HbA1c<br>5.6% @ 11.3% HbA1c | Whole blood application:<br>Within run:<br>0.8% @ 5.4% HbA1c<br>0.9% @ 10.2% HbA1c<br><br>Between day:<br>1.3% @ 5.3% HbA1c<br>1.0% @ 10.3% HbA1c<br><br>Hemolysate application<br>Within run:<br>1.0% @ 55% HbA1c<br>0.6% @ 10.6% HbA1c<br><br>Between day:<br>1.0% @ 5.3% HbA1c<br>0.8% @ 10.7% HbA1c |
| Linearity | 0.3 g/dL up to highest calibrator for<br>HbA1c.<br>9-24 g/dL Hb<br>(before dilution) | 0.3-2.6 g/dL HbA1c<br>4-35 g/dL Hb<br>(before dilution)<br>(Based on highest calibrator value) |
| Lower detection<br>limit | 0.3 g/dL HbA1c | 0.02 g/dL HbA1c<br>0.09 g/dL Hb |
| Endogenous<br>interferences | No interference from Acetylsalicylic<br>acid; Gamma globulin; Rheumatoid<br>factor or ascorbic acid | Whole blood application:<br>No significant interference from:<br>Icterus |
| | Lipemia up to 17.5 mg/dL | Lipemia: up to 800 mg/dL |
| | Lipemia (intralipid) up to 1230 mg/dL | Intralipid |
| | | Rheumatoid factor: up to 750<br>IU/mL |
| | | Glycemia: up to 1000 mg/dL<br>glucose |
| Expected values | 4.3% - 5.8% HbA1c<br>Based on 1993 study with in-house<br>standardization | 2.9-4.2% HbA1c<br>Based on study done with IFCC<br>standardization |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

SEP 3 0 2005

Ms. Theresa Ambrose Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250

Re: k052464

Trade/Device Name: Tina-Quant® Hemoglobin A1c Gen.2 Test Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 07, 2005 Received: September 08, 2005

Dear Ms. Ambrose:

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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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, 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): K052464

Device Name: Tina-Quant® Hemoglobin A1c Gen.II

Indications For Use:

The Tina-Quant Hemoglobin A1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin A 1c in whole blood. HbAlc results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

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510(k) k052464