TQ HBA1C GEN3

K102914 · Roche · LCP · Jan 20, 2011 · Hematology

Device Facts

• Record ID: K102914
• Device Name: TQ HBA1C GEN3
• Applicant: Roche
• Product Code: LCP · Hematology
• Decision Date: Jan 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Tina-Quant Hemoglobin A1c Gen. test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c ((DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Story

Tina-quant HbA1c Gen. 3 is an in vitro diagnostic reagent system for use on Roche COBAS INTEGRA 800 analyzers. It processes anticoagulated whole blood or hemolysate samples. The device uses a turbidimetric inhibition immunoassay (TINIA) where HbA1c in the sample competes with polyhapten for binding to sheep polyclonal anti-HbA1c antibodies, forming insoluble complexes. Total hemoglobin is measured bichromatically after conversion to a derivative. The instrument calculates % HbA1c or mmol/mol HbA1c using user-selected protocols. Used in clinical laboratories by technicians; results assist physicians in monitoring long-term glycemic control in diabetic patients.

Clinical Evidence

Bench testing only. Performance evaluated via repeatability and intermediate precision studies using human samples and controls. Analytical sensitivity (LoB/LoD) and interference testing (lipemia, icterus, rheumatoid factors) were performed. Results demonstrate comparability to the predicate device.

Technological Characteristics

In vitro diagnostic reagent system; turbidimetric inhibition immunoassay (TINIA); bichromatic photometry for total hemoglobin; sheep polyclonal anti-HbA1c antibodies; automated on-board sample pretreatment; compatible with COBAS INTEGRA 800 analyzers; Spline calibration mode.

Indications for Use

Indicated for the quantitative determination of HbA1c in whole blood or hemolysate 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 HbA1c Gen 2 (K072714)

Submission Summary (Full Text)

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510(k) Summary – Hemoglobin Gen. 3

# 510(k) Summary – Hemoglobin Gen. 3

Introduction

Roche Diagnostics Corporation hereby submits this Special 510(k) according to
the requirements of 21 CFR 807.92. to provides sufficient detail to understand
the basis for a determination of
substantial equivalence for the Tina-quant HbA1c assay Gen 3.

Submitter.
name. address.
contact

Roche Diagnostics
9115 Hague Road
PO Box 50416
Indianapolis. IN 46250
Phone: [phone]
Fax: [phone]

Contact person: Kathie Goodwin

Date prepared: 9/31/2010

Device name

Proprietary name: Tina-quant HbA1c Gen. 3

Common name: HbA1c Gen. 3

Classification name: Glycosylated Hemoglobin Assay

Product code: LCP

Device
description

With the Tina-Quant Hemoglobin A1c Gen. 3 test system. the anticoagulated
whole blood specimen is hemolyzed prior to determination of HbA1c 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 % HbA1c from the HbA1c/ Hb ratio according to a user selected protocol.

Intended use

The Tina-Quant Hemoglobin A1c Gen. test is in vitro diagnostic reagent system
intended for use on the COBAS INTEGRA 800 analyzers for the quantitative
determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c
((DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry
analyzers. HbA1c determinations 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 HbA1c Gen 2 assay cleared
in K072714.

Continued on next nage

JAN 2 0 2011

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## 510(k) Summary - insert device name. Continued

Substantial The following table compares the HbA1c Gen 2 assay with the HbA1c equivalence -Gen. 3 assay. similarities and differences

and the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contributio

| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Whole blood application<br>In vitro test for the<br>quantitative determination of<br>percent hemoglobin A1c<br>[HbA1c (%)] in whole blood<br>on Roche clinical chemistry<br>analyzers<br>.<br>Hemolysate Application:<br>In vitro test for the<br>Quantitative determination<br>of percent hemoglobin A1c<br>[HbA1c (%)] in hemolysate<br>prepared from whole blood<br>on Roche clinical chemistry<br>analyzers | Whole blood application<br>In vitro test for the<br>quantitative determination<br>of mmol/mol hemoglobin<br>A1c (IFCC) and %<br>hemoglobin A1c (<br>DCCT/NGSP) in whole<br>blood on Roche clinical<br>chemistry analyzers<br><br>Hemolysate Application<br>In vitro test for the<br>quantitative determination<br>of mmol/mol hemoglobin<br>A1c (IFCC) and percent<br>hemoglobin A1c (<br>DCCT/NGSP) in<br>hemolysate prepared from<br>whole blood on Roche<br>clinical chemistry<br>analyzers. |
| Assay Protocol | | |
| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 |
| Sample Types | Whole blood/Hemolysate<br>applications:<br>Anticoagulated venous or<br>capillary blood with the<br>following anticoagulants:<br>Li-heparin<br>Na-heparin<br>K2-EDTA<br>K3-EDTA<br>potassium fluoride/Na2-EDTA<br>Sodium fluoride/Na-EDTA<br>Sodium fluoride/potassium oxalate | Whole blood/Hemolysate<br>applications:<br>Anticoagulated venous or<br>capillary blood with the<br>following anticoagulants:<br>Li-heparin<br>Na-heparin<br>K2-EDTA<br>K3-EDTA<br>potassium fluoride/Na2-EDTA<br>Sodium fluoride/Na-EDTA<br>Sodium fluoride/potassium oxalate |
| Labeled Instrument<br>Platform | Integra 400/400 plus<br>Integra 800 | same |
| Calibrator | Cfas HbA1c | same |
| Calibration Frequency | Each lot. every 29 days. and<br>as required following quality<br>control procedures | same |
| Calibration mode | Logit/log 5 | Spline |
| Controls | HbA1c Control N<br>HbA1c Control P | same |
| Reagent Stability | 2-8 °C until expiration date<br>on-board in use @ 8°C 28<br>days | Same<br>Integra 400/400plus:<br>on board in use @ 10-15°C<br>28 days<br>Integra 800<br>on-board in use @ 8°C: 28<br>days |

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| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 | | | | | | | | | | | | | | | | | | | | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Measuring Range | Integra 400/400 plus<br>Hb: 4 – 35 g/dL<br>HbA1c: 0.3 – 2.6 g/dL*<br><br>* Based on concentration of<br>the highest standard<br><br>Integra 800<br>Hb: 4 – 35 g/dL<br>HbA1c: 0.3 – 3.4 g/dL* | Integra 400/400 plus<br>Hb: 4 – 40 g/dL<br>HbA1c: same<br><br>Integra 800<br>Hb: 4 – 40 g/dL<br>HbA1c: 0.3 – 2.6 g/dL | | | | | | | | | | | | | | | | | | | | | |
| Precision | Whole blood application<br>Within-run:<br><br>0.8% @ 5.4% HbA1c<br>0.9% @ 10.2% HbA1c | Whole blood application<br>Repeatability:<br>sample % CV %HbA1c HbA1c<br>Control N 1.1 5.6 HbA1c<br>Control P 0.8% 10.3 human<br>sample 1 0.9% 4.7 human<br>sample 2 0.8 5.8 human<br>sample 3: 0.7 8.7 human<br>sample 4 1.5 12.4 | | | | | | | | | | | | | | | | | | | | | |
| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 | | | | | | | | | | | | | | | | | | | | | |
| Precision, cont... | Whole blood application, cont...<br><br>Between day<br>1.3% @ 5.3 % HbA1c<br>1.0% @ 10.3 % HbA1c | Whole blood application, cont...<br><br>Intermediate precision: | | | | | | | | | | | | | | | | | | | | | |
| | | sample % CV %HbA1c HbA1c Control N 1.3 5.6 HbA1c Control P 0.9 10.3 human sample 1 1.1 4.7 human sample 2 1.1 5.8 human sample 3: 0.8 8.7 human sample 4 1.6 12.4 | | | | | | | | | | | | | | | | | | | | | |
| | Hemolysate Application:<br>Within-run:<br>1.0% @ 5.5 % HbA1c<br>0.6% @ 10.6 % HbA1c | Hemolysate Application<br>Repeatability: | | | | | | | | | | | | | | | | | | | | | |
| | | sample % CV %HbA1c HbA1c Control N 0.9 5.6 HbA1c Control P 0.9 10.1 human sample 1 1.0 4.7 human sample 2 0.9 5.8 human sample 3: 0.8 8.7 human sample 4 1.2 12.0 | | | | | | | | | | | | | | | | | | | | | |
| | Between day<br>1.0% @ 5.3 % HbA1c<br>0.8% @ 10.7 % HbA1c | Intermediate precision: | | | | | | | | | | | | | | | | | | | | | |
| | | sample % CV %HbAlc HbAlc Control N 1.3 5.6 HbAlc Control P 0.9 10.1 human sample 1 1.2 4.7 human sample 2 1.0 5.8 human sample 3: 0.9 8.7 human sample 4 1.5 12.0 | | | | | | | | | | | | | | | | | | | | | |

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| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Analytical Sensitivity | LDL<br>Hb: 0.5 g/dL<br>HbA1c: 0.1 g/dL | LoB<br>Hb=0.50 g/dL<br>HbA1c: 0.19 g/dL<br><br>LoD<br>Hb=1.0 g/dL<br>HbA1c: 0.29 g/dL |
| Analytical Specificity | Hb:<br>Labile HbA1c (pre-HbA1c).<br>acetylated Hb. carbamylated<br>Hb do not affect the assay<br>result | same |
| | Hb variants:<br>Specimens containing high<br>amounts of HbF(> 10%)<br>may yield lower than<br>expected HbA1c results | same |
| Endogenous<br>Interferences | Icterus: no significant<br>interference | Same |
| | Lipemia: no significant<br>interference up to a<br>triglycerides conc of 600<br>mg/dL ( Integra 400/400<br>plus)<br>and 800 mg/dL (Integra 800) | Lipemia: no significant<br>interference up to a<br>Intralipid conc of 800<br>mg/dL |
| | and 800 mg/dL (Integra 800) | same |
| | Rheumatoid factors: no<br>significant interference up to<br>750 IU/mL | same |
| | Glycemia: no significant<br>interference up to 1000<br>mg/dL | |
| Expected Values | 2.9 - 4.2 % HbA1c ( acc. to<br>IFCC) | 29 - 42 mmol/L HbA1c<br>(acc. IFCC) |
| | 4.8 -5.9 % HbA1c (acc. to<br>DCCT/NGSP) | same |
| Feature | HbA1c Gen. 2<br>K072714 | HbA1c Gen. 3 |
| Determination of<br>HbA1c | Turbidimetric<br>immunoinhibition (TINIA).<br>Antigen-antibody complexes<br>are formed and excess Ab<br>aggregate with polyhapten to<br>form insoluble complexes | same |
| Determination of Hb | Bichromatic photometric<br>determination after<br>conversion to a colored<br>derivate | same |
| Pretreatment | Whole blood application<br>automated on-board sample<br>pretreatment with<br>hemolyzing reagent<br><br>Hemolysate Application:<br>Manual pretreatment with<br>hemolyzing reagent | same |
| Antibody | Polyclonal anti-HbA1c from<br>sheep blood | same |
| Reporting units | % HbA1c NGSP / DCCT | mmol/mol IFCC<br>% HbA1c NGSP/DCCT |
| Equation used for final<br>HbA1c value | Protocol 1 ( acc. to IFCC)<br>$HbA1c(%)=(HbA1c/Hb)x100$<br><br>Protocol 2 ( acc. to DCCT/NGSP)<br>$HbA1c(%)=(HbA1c/Hb)x87.6+2.27$ | Protocol 1 ( acc. to IFCC)<br>$HbA1c(mmol/mol)=(HbA1c/Hb)x1000$<br><br>Protocol 2(acc. toDCCT/NGSP)<br>$HbA1c(%)=(HbA1c/Hb)x91.5+2.15$ |

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing left and has a flowing, abstract design. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics Corporation c/o Ms. Kathie Goodwin 9115 Hague Road Indianapolis, Indiana 46250

JAN 200 201

Re: k102914

> Trade Name: Roche Tina Quant HbA1c Gen. 3 Assay Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Codes: LCP Dated: December 20, 2010 Received: December 21, 2010

Dear Ms. Goodwin:

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).

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lf you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. 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 Form

510(k) Number (if known): K 102914

Device Name: Tina-quant HbA Ic Gen. 3

Indications for Use:

The Tina-Quant Hemoglobin Alc Gen. test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of mmol/mol hemoglobin A 1c (IFCC) and % hemoglobin A 1c ((DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbA Ic determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Signature

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

510(k) K102914

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