(324 days)
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.
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.
The provided document is a 510(k) Summary for the Tina-quant HbA1c Gen.2 Assay. It outlines the device's intended use and compares it to a predicate device but does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against these criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document primarily focuses on establishing substantial equivalence to a previously cleared device (K072714) by comparing features and intended uses. It lists some analytical characteristics like precision and sensitivity, but these are presented as inherent features of the device rather than results of a specific study proving acceptance criteria.
To answer your request thoroughly, I would need a different type of document, such as a full study report or a detailed validation section, that explicitly states acceptance criteria and presents data demonstrating that the device meets them.
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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 Diagnostics9115 Hague RoadPO Box 50416Indianapolis, IN 46250Phone: 317-521-3380Fax: 317-521-2324 | ||||
| Contact person: Susan HollandbeckEmail:susan.hollandbeck@roche.comFax:(317) 521-3380 Date prepared: January 31, 2011 | Email: | susan.hollandbeck@roche.com | Fax: | (317) 521-3380 | |
| Email: | susan.hollandbeck@roche.com | ||||
| Fax: | (317) 521-3380 | ||||
| Device name | Proprietary name: Tina-quant Hemoglobin A1c Gen.2 assayCommon name: HbA1c Gen.2Classification name: Glycosylated Hemoglobin assayProduct 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:HbA1c Gen. 2 (K072714) | Candidate Device:HbA1c Gen. 2 |
|---|---|---|
| Intended Use | Whole blood applicationIn vitro test for the quantitativedetermination of percenthemoglobin A1c [HbA1c (%)]in whole blood on Rocheclinical chemistry analyzers | Whole blood applicationIn vitro test for the quantitativedetermination of mmol/molhemoglobin Alc (IFCC) and %hemoglobin Alc(DCCT/NGSP) in whole bloodon Roche clinical chemistryanalyzers |
| Hemolysate Application:In vitro test for the Quantitativedetermination of percenthemoglobin A1c [HbA1c (%)]in hemolysate prepared fromwhole blood on Roche clinicalchemistry analyzers | Hemolysate ApplicationIn vitro test for the quantitativedetermination of mmol/molhemoglobin A1c (IFCC) and% hemoglobin Alc(DCCT/NGSP) in hemolysateprepared from whole blood onRoche clinical chemistryanalyzers | |
| Sample Types | Anticoagulated venous or capillarybloodAcceptable anticoagulants for both | Anticoagulated venous orcapillary bloodAcceptable anticoagulants for both |
| the hemolysate and whole bloodapplications include• Li-heparin• K2-EDTA• K3-EDTA• KF/Na2-EDTA | the hemolysate and whole bloodapplications include• Li-Heparin• K2-EDTA• K3-EDTA• KF/Na2-EDTA | |
| Acceptable anticoagulants for thehemolysate application include• Na-Heparin• NaF/K-Oxalate | ||
| Feature | Predicate Device: | Candidate Device: |
| HbA1c Gen. 2 (K072714) | HbA1c Gen. 2 | |
| InstrumentPlatform | Integra 400/400 plusIntegra 800 and Integra 800 CTS(Closed Tube system) | same |
| Calibrator | Cfas HbAlc | same |
| CalibrationFrequency | Each lot, every 29 days, and asrequired following quality controlprocedures | same |
| CalibrationMode | Logit/log 5 | same |
| Controls | HbAlc Control NHbAlc Control P | HbAlc Control NHbA1c Control PPreciControl HbAlc normand path (cleared in K103099) |
| ReagentStability | Unopened2-8 °C until expiration dateOn-board in useIntegra 400/400plus10-15°C for 28 daysIntegra 8008°C for 28 days | same |
| MeasuringRange | Integra 400/400 plusHb: 4 – 35 g/dLHbA1c: 0.3 – 2.6 g/dL** Based on concentration of thehighest standard. This test range isbased on a typical calibrator valueof 2.6 g/dL.Integra 800Hb: 4 – 35 g/dLHbAlc: 0.3 – 3.4 g/dL | same |
| Reporting Units | % HbAlc NGSP / DCCT | % HbAlc NGSP/DCCT andmmol/mol IFCC |
| Antibody | Polyclonal anti-HbA1c from sheepblood | same |
| Feature | Predicate Device:HbA1c Gen. 2 (K072714) | Candidate Device:HbA1c Gen. 2 |
| Precision | Whole blood applicationWithin-run:0.8% @ 5.4 % HbA1c0.9% @ 10.2 % HbA1c | same |
| Between day:1.3% @ 5.3 % HbA1c1.0% @ 10.3 % HbA1c | ||
| Hemolysate Application:Within-run:1.0% @ 5.5 % HbA1c0.6% @ 10.6 % HbA1c | Change in nomenclature:"Within-run" is now called"Repeatability" and "Between dayis now called "Intermediateprecision." | |
| Between day:1.0 % @ 5.3 % HbA1c0.8% @ 10.7 % HbA1c | ||
| ExpectedValues | Protocol 12.9 – 4.2 % HbA1c(acc. to IFCC) | Protocol 129 – 42 mmol/mol HbA1c(acc. IFCC) |
| Protocol 24.8 -5.9 % HbA1c(acc. to DCCT/NGSP) | Protocol 2same | |
| Determinationof HbA1c | Turbidimetric immunoinhibition(TINIA). Antigen-antibodycomplexes are formed and excessAb aggregate with polyhapten toform insoluble complexes | same |
| Determinationof Hb | Bichromatic photometricdetermination after conversion to acolored derivate | same |
| Pretreatment | Whole blood applicationautomated on-board samplepretreatment with hemolyzingreagent | same |
| Hemolysate Application: | ||
| Manual pretreatment with | ||
| hemolyzing reagent | ||
| Feature | Predicate Device:HbA1c Gen. 2 (K072714) | Candidate Device:HbA1c Gen. 2 |
| AnalyticalSensitivity | LDLHb: 0.5 g/dLHbA1c: 0.1 g/dL | LOB and LODHb:LOB = 0.31 mmol/L (0.50 g/dL)LOD = 0.62 mmol/L (1.0 g/dL)HbA1c:LOB = 0.12 mmol/L (0.19 g/dL)LOD = 0.18 mmol/L (0.29 g/dL) |
| AnalyticalSpecificity | Hb derivates:Labile HbA1c (pre-HbA1c),acetylated Hb, carbamylated Hbdo not affect the assay resultHb variants:Specimens containing highamounts of HbF (> 10 %) mayyield lower than expected HbA1cresults | same |
| EndogenousInterferences | Icterusno significant interferenceRheumatoid factorsno significant interference up to750 IU/mLGlycemiano significant interference up to1000 mg/dLLipemiaIntegra 400/400 plus analyzers:No significant interference up to atriglycerides concentration of 600mg/dLIntegra 800 analyzer:No significant interference up to atriglycerides concentration of 800mg/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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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-5680 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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).