TINA-QUANT HBA1C GEN.2

K110313 · Roche Diagnostics · LCP · Dec 23, 2011 · Hematology

Device Facts

• Record ID: K110313
• Device Name: TINA-QUANT HBA1C GEN.2
• Applicant: Roche Diagnostics
• Product Code: LCP · Hematology
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Tina-Quant hemoglobin A1c Gen.2 assay is an in vitro diagnostic reagent system intended for 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

The Tina-quant HbA1c Gen.2 assay is an in vitro diagnostic reagent system used on Roche clinical chemistry analyzers to measure HbA1c levels in anticoagulated whole blood or hemolysate. The system utilizes a turbidimetric inhibition immunoassay (TINIA); antigen-antibody complexes form, and excess antibody aggregates with polyhapten to create insoluble complexes. Hemoglobin is measured bichromatically after conversion to a colored derivative. The instrument calculates the % HbA1c from the HbA1c/Hb ratio. The assay is intended for use by healthcare professionals in clinical settings to monitor long-term blood glucose control in diabetic patients. Results assist clinicians in assessing glycemic management.

Clinical Evidence

Bench testing only. Precision studies (n=90 low, n=25 medium, n=19 high) compared candidate anticoagulants against K2-EDTA predicate, showing comparable SD and CV. Matrix comparison (n=132) using Passing/Bablock regression confirmed equivalence across anticoagulants. Method comparison between whole blood and hemolysate applications showed high correlation (r > 0.99). LoB (2.3%) and LoD (2.5%) established per CLSI EP17-A.

Technological Characteristics

Turbidimetric inhibition immunoassay (TINIA) for HbA1c; bichromatic photometry for total hemoglobin. Uses sheep-derived polyclonal anti-HbA1c antibodies. Compatible with Roche Integra 400/400 plus and 800/800 CTS analyzers. Calibration via Logit/log 5 mode. Reagent stability: 2-8°C unopened; 10-15°C (Integra 400) or 8°C (Integra 800) on-board.

Indications for Use

Indicated for monitoring long-term blood glucose control in individuals with diabetes mellitus. Used for quantitative determination of HbA1c in hemolysate or whole blood samples.

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 (K072714)

Submission Summary (Full Text)

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K110313

DEC 2 3 2011

# 510(k) Summary – Tina-quant HbA1c Gen.2 Assay

| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of our intent to market Tina-quant HbA1c Gen.2 assay. | | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------|------|----------------|
| Submitter, name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>PO Box 50416<br>Indianapolis, IN 46250<br>Phone: [phone]<br>Fax: [phone] | | | | |
| | Contact person: Susan Hollandbeck<br><table><tr><td>Email:</td><td>[e-mail]</td></tr><tr><td>Fax:</td><td>[phone]</td></tr></table> Date prepared: January 31, 2011 | Email: | [e-mail] | Fax: | [phone] |
| Email: | [e-mail] | | | | |
| Fax: | [phone] | | | | |
| Device name | Proprietary name: Tina-quant Hemoglobin A1c Gen.2 assay<br>Common name: HbA1c Gen.2<br>Classification name: Glycosylated Hemoglobin assay<br>Product code: LCP | | | | |
| Device description | With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA1c by a 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. | | | | |

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| Intended use | The Tina-Quant Hemoglobin A1c Gen.2 assay is an in vitro diagnostics reagent system intended for 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 currently marketed device Tina-quant Hemoglobin A1c Gen.2 cleared in K072714. |

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| Feature | Predicate Device:<br>HbA1c Gen. 2 (K072714) | Candidate Device:<br>HbA1c Gen. 2 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Whole blood application<br>In vitro test for the quantitative<br>determination of percent<br>hemoglobin A1c [HbA1c (%)]<br>in whole blood on Roche<br>clinical chemistry analyzers | Whole blood application<br>In vitro test for the quantitative<br>determination of mmol/mol<br>hemoglobin Alc (IFCC) and %<br>hemoglobin Alc<br>(DCCT/NGSP) in whole blood<br>on Roche clinical chemistry<br>analyzers |
| | Hemolysate Application:<br>In vitro test for the Quantitative<br>determination of percent<br>hemoglobin A1c [HbA1c (%)]<br>in hemolysate prepared from<br>whole blood on Roche clinical<br>chemistry analyzers | Hemolysate Application<br>In vitro test for the quantitative<br>determination of mmol/mol<br>hemoglobin A1c (IFCC) and<br>% hemoglobin Alc<br>(DCCT/NGSP) in hemolysate<br>prepared from whole blood on<br>Roche clinical chemistry<br>analyzers |
| Sample Types | Anticoagulated venous or capillary<br>blood<br>Acceptable anticoagulants for both | Anticoagulated venous or<br>capillary blood<br>Acceptable anticoagulants for both |
| | the hemolysate and whole blood<br>applications include<br>• Li-heparin<br>• K2-EDTA<br>• K3-EDTA<br>• KF/Na2-EDTA | the hemolysate and whole blood<br>applications include<br>• Li-Heparin<br>• K2-EDTA<br>• K3-EDTA<br>• KF/Na2-EDTA |
| | | Acceptable anticoagulants for the<br>hemolysate application include<br>• Na-Heparin<br>• NaF/K-Oxalate |
| Feature | Predicate Device: | Candidate Device: |
| | HbA1c Gen. 2 (K072714) | HbA1c Gen. 2 |
| Instrument<br>Platform | Integra 400/400 plus<br>Integra 800 and Integra 800 CTS<br>(Closed Tube system) | same |
| Calibrator | Cfas HbAlc | same |
| Calibration<br>Frequency | Each lot, every 29 days, and as<br>required following quality control<br>procedures | same |
| Calibration<br>Mode | Logit/log 5 | same |
| Controls | HbAlc Control N<br>HbAlc Control P | HbAlc Control N<br>HbA1c Control P<br>PreciControl HbAlc norm<br>and path (cleared in K103099) |
| Reagent<br>Stability | Unopened<br>2-8 °C until expiration date<br>On-board in use<br>Integra 400/400plus<br>10-15°C for 28 days<br>Integra 800<br>8°C for 28 days | same |
| Measuring<br>Range | Integra 400/400 plus<br>Hb: 4 – 35 g/dL<br>HbA1c: 0.3 – 2.6 g/dL*<br>* Based on concentration of the<br>highest standard. This test range is<br>based on a typical calibrator value<br>of 2.6 g/dL.<br>Integra 800<br>Hb: 4 – 35 g/dL<br>HbAlc: 0.3 – 3.4 g/dL | same |
| Reporting Units | % HbAlc NGSP / DCCT | % HbAlc NGSP/DCCT and<br>mmol/mol IFCC |
| Antibody | Polyclonal anti-HbA1c from sheep<br>blood | same |
| Feature | Predicate Device:<br>HbA1c Gen. 2 (K072714) | Candidate Device:<br>HbA1c Gen. 2 |
| 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 | Change in nomenclature:<br>"Within-run" is now called<br>"Repeatability" and "Between day<br>is now called "Intermediate<br>precision." |
| | Between day:<br>1.0 % @ 5.3 % HbA1c<br>0.8% @ 10.7 % HbA1c | |
| | | |
| Expected<br>Values | Protocol 1<br>2.9 – 4.2 % HbA1c<br>(acc. to IFCC) | Protocol 1<br>29 – 42 mmol/mol HbA1c<br>(acc. IFCC) |
| | Protocol 2<br>4.8 -5.9 % HbA1c<br>(acc. to DCCT/NGSP) | Protocol 2<br>same |
| | | |
| Determination<br>of 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<br>of Hb | Bichromatic photometric<br>determination after conversion to a<br>colored derivate | same |
| Pretreatment | Whole blood application<br>automated on-board sample<br>pretreatment with hemolyzing<br>reagent | same |
| | Hemolysate Application: | |
| | Manual pretreatment with | |
| | hemolyzing reagent | |
| Feature | Predicate Device:<br>HbA1c Gen. 2 (K072714) | Candidate Device:<br>HbA1c Gen. 2 |
| Analytical<br>Sensitivity | LDL<br>Hb: 0.5 g/dL<br>HbA1c: 0.1 g/dL | LOB and LOD<br>Hb:<br>LOB = 0.31 mmol/L (0.50 g/dL)<br>LOD = 0.62 mmol/L (1.0 g/dL)<br>HbA1c:<br>LOB = 0.12 mmol/L (0.19 g/dL)<br>LOD = 0.18 mmol/L (0.29 g/dL) |
| Analytical<br>Specificity | Hb derivates:<br>Labile HbA1c (pre-HbA1c),<br>acetylated Hb, carbamylated Hb<br>do not affect the assay result<br>Hb variants:<br>Specimens containing high<br>amounts of HbF (> 10 %) may<br>yield lower than expected HbA1c<br>results | same |
| Endogenous<br>Interferences | Icterus<br>no significant interference<br>Rheumatoid factors<br>no significant interference up to<br>750 IU/mL<br>Glycemia<br>no significant interference up to<br>1000 mg/dL<br>Lipemia<br>Integra 400/400 plus analyzers:<br>No significant interference up to a<br>triglycerides concentration of 600<br>mg/dL<br>Integra 800 analyzer:<br>No significant interference up to a<br>triglycerides concentration of 800<br>mg/dL | same |

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### Substantial equivalence (continued)

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Substantial equivalence (continued)

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#### Substantial equivalence (continued)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with flowing lines representing movement or connection.

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

Roche Diagnostics Corporation c/o Susan Hollandbeck 9115 Hague Road Indianapolis, Indiana 46250

DEC 2 3 2011

k110313 Re: Trade Name: Roche Tina Quant HbA1c Gen. 2 Assay Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Codes: LCP Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. Hollandbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the we have fevenced above and have determined the device is substantially equivalent (for de receiers 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 marketou in meetstate 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 with the provisions of anapproval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls device, subject to the Act include requirements for annual registration, listing of devices, provisions of the incentive, 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 (I MA), it may be subject to sam adam alled of Federal Regulations (CFR), Parts arrecting your do rous on, 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 I lease be advised that I made a determination that your device complies with other not firements of the Act or any Federal statutes and regulations administered by other requirements of the Free of at comply with all the Act's requirements, including, but not i carear agenciestration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 607), modical as not reportant firing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire 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 CI K Far 607.97): For questions regarding (OSB's) Division of Postmarket Surveillance at (301) Office of Daily of the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may 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,

signature

Counney 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

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## Indications for Use Form

510(k) Number (if known): K |10313

Device Name: Tina-quant HbA1c Gen.2

Indications for Use:

The Tina-Quant Hemoglobin A1c Gen. 2 assay is an in vitro diagnostic reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbA lc (DCC (ACOT) in nonitoring 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) K110313