(111 days)
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.
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.
The Roche Tina-quant HbA1c Gen. 3 Assay is an in vitro diagnostic reagent system for the quantitative determination of HbA1c in hemolysate or whole blood. It is intended for monitoring long-term blood glucose control in individuals with diabetes mellitus.
Here's an analysis of its acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" as a single, clearly defined set of thresholds that the device must meet in a comparative study. Instead, it presents performance characteristics of the new HbA1c Gen. 3 assay alongside those of its predicate device, HbA1c Gen. 2 (K072714). The implicit acceptance criteria are that the Gen. 3 assay performs equivalently or better than the Gen. 2 assay, or meets established clinical and analytical standards for HbA1c testing.
Based on the provided information, we can extract and compare the reported performance:
| Feature | HbA1c Gen. 2 (Predicate) | HbA1c Gen. 3 (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of percent hemoglobin A1c [HbA1c (%)] in whole blood/hemolysate on Roche clinical chemistry analyzers. | Quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in whole blood/hemolysate on Roche clinical chemistry analyzers. (Adds IFCC units) |
| Measuring Range | Integra 400/400 plus: Hb: 4 – 35 g/dL, HbA1c: 0.3 – 2.6 g/dLIntegra 800: Hb: 4 – 35 g/dL, HbA1c: 0.3 – 3.4 g/dL | Integra 400/400 plus: Hb: 4 – 40 g/dL, HbA1c: same (0.3 – 2.6 g/dL)Integra 800: Hb: 4 – 40 g/dL, HbA1c: 0.3 – 2.6 g/dL (Hb range increased, HbA1c range slightly narrower than Gen 2 on Integra 800 but still within clinical relevance) |
| Precision (Whole Blood) | Within-run:0.8% @ 5.4% HbA1c0.9% @ 10.2% HbA1cBetween day:1.3% @ 5.3 % HbA1c1.0% @ 10.3 % HbA1c | Repeatability (Within-run):sample % CV %HbA1cControl N 1.1 5.6Control P 0.8% 10.3human sample 1 0.9% 4.7human sample 2 0.8 5.8human sample 3: 0.7 8.7human sample 4 1.5 12.4Intermediate precision (Between day):sample % CV %HbA1cControl N 1.3 5.6Control P 0.9 10.3human sample 1 1.1 4.7human sample 2 1.1 5.8human sample 3: 0.8 8.7human sample 4 1.6 12.4(Generally comparable or slightly better performance; reported in more detail) |
| Precision (Hemolysate) | Within-run:1.0% @ 5.5 % HbA1c0.6% @ 10.6 % HbA1cBetween day:1.0% @ 5.3 % HbA1c0.8% @ 10.7 % HbA1c | Repeatability (Within-run):sample % CV %HbA1cControl N 0.9 5.6Control P 0.9 10.1human sample 1 1.0 4.7human sample 2 0.9 5.8human sample 3: 0.8 8.7human sample 4 1.2 12.0Intermediate precision (Between day):sample % CV %HbAlcControl N 1.3 5.6Control P 0.9 10.1human sample 1 1.2 4.7human sample 2 1.0 5.8human sample 3: 0.9 8.7human sample 4 1.5 12.0(Generally comparable or slightly better performance; reported in more detail) |
| Analytical Sensitivity | LDLHb: 0.5 g/dLHbA1c: 0.1 g/dL | LoB (Limit of Blank):Hb=0.50 g/dLHbA1c: 0.19 g/dLLoD (Limit of Detection):Hb=1.0 g/dLHbA1c: 0.29 g/dL(LoB/LoD are different metrics than LDL, but overall indicates very low detection limits, aligning with the predicate) |
| Analytical Specificity | Labile HbA1c, acetylated Hb, carbamylated Hb do not affect result. HbF (> 10%) may yield lower results. | Same as predicate. |
| Endogenous Interferences | Icterus: no significant interference.Lipemia: no significant interference up to 600 mg/dL (Integra 400/400 plus) and 800 mg/dL (Integra 800) triglycerides.Rheumatoid factors: no significant interference up to 750 IU/mL.Glycemia: no significant interference up to 1000 mg/dL. | Icterus: Same.Lipemia: no significant interference up to 800 mg/dL Intralipid (This is a different metric than triglycerides but covers a wide range).Rheumatoid factors: Same.Glycemia: Not explicitly stated for Gen 3, but likely similar or covered by other equivalency claims. |
| Reporting Units | % HbA1c NGSP / DCCT | mmol/mol IFCC% HbA1c NGSP/DCCT (Adds IFCC units) |
| Equation for final HbA1c | Protocol 1 (IFCC): $HbA1c(%)=(HbA1c/Hb)x100$Protocol 2 (DCCT/NGSP): $HbA1c(%)=(HbA1c/Hb)x87.6+2.27$ | Protocol 1 (IFCC): $HbA1c(mmol/mol)=(HbA1c/Hb)x1000$Protocol 2 (DCCT/NGSP): $HbA1c(%)=(HbA1c/Hb)x91.5+2.15$ (Equations are updated for both protocols, maintaining the dual reporting capability) |
The primary acceptance outcome demonstrated is that the Tina-quant HbA1c Gen. 3 assay maintains similar or improved analytical performance characteristics (precision, linearity, specificity, and interference) compared to its predicate device, the Tina-quant HbA1c Gen 2 assay. The addition of IFCC reporting units and updated calculation protocols, along with an extended Hb measuring range, represent enhancements that are accepted as substantially equivalent for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document presents performance data across various studies (e.g., precision, measuring range, analytical sensitivity, interference).
- Precision: The precision studies (repeatability and intermediate precision) utilized:
- HbA1c Control N
- HbA1c Control P
- Four human samples with varying HbA1c levels.
The specific number of replicates or individual patient samples for repeatability and intermediate precision, or the total sample size across all categories for these studies, is not explicitly stated beyond "human sample 1, 2, 3, 4" and the controls.
- Other studies (Analytical Sensitivity, Interferences): The sample sizes for these tests are not explicitly quantified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that Roche Diagnostics is based in Indianapolis, IN, USA, and the 510(k) is submitted to the FDA, it's reasonable to infer that studies were likely conducted to meet U.S. regulatory standards, but the exact geographical origin of the samples is not stated. The type of studies described (precision, sensitivity, interference) are typically prospective, laboratory-based analytical validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is an in vitro diagnostic assay, meaning its "ground truth" is established through analytical methods and reference materials, not through expert consensus on medical images or clinical diagnoses.
- Ground Truth for Analytical Performance: The "ground truth" for evaluating the assay's performance would be established by:
- Certified Reference Materials: For HbA1c, this would involve materials traceable to an international reference system, such as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method for HbA1c.
- Calibrators and Controls: The document mentions "Cfas HbA1c" as a calibrator and "HbA1c Control N" and "HbA1c Control P" as controls. These would have assigned values based on rigorous analytical standards and reference methods.
- Comparative methods: Often, new assays are compared against established, validated methods. While not explicitly detailed as a "ground truth" expert, the predicate device itself serves as a comparative benchmark.
Therefore, there are no "experts" in the sense of clinicians or radiologists establishing ground truth for individual test cases. Instead, the ground truth is analytically derived and traceable to internationally recognized standards for HbA1c measurement.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic device primarily evaluated on analytical performance characteristics (precision, accuracy against reference methods, linearity, interference), there is no adjudication process involving multiple human reviewers interpreting results in the way it would apply to imaging studies or clinical trials. The evaluation relies on quantitative measurements and statistical analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for diagnostic imaging systems where human readers interpret medical images. This device is an automated in vitro diagnostic assay for measuring a biochemical marker. Therefore, an MRMC comparative effectiveness study was not conducted or applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the assay system (reagents + instrument). The "algorithm" in this context refers to the assay's chemical reactions and the instrument's photometric measurements and calculations. The precision, sensitivity, and interference studies directly assess the performance of the automated system without requiring human interpretation as part of the primary measurement. Human involvement would primarily be in sample preparation, loading, and quality control monitoring, not in providing a "human-in-the-loop" interpretation that modifies the directly reported numerical result.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance of the Tina-quant HbA1c Gen. 3 assay is primarily based on analytical reference methods and certified reference materials.
- Accuracy and calibration would be traceable to recognized HbA1c reference methods (e.g., IFCC reference method) or standards (e.g., NGSP certification).
- Control materials mentioned (Control N, Control P) have established target values.
- Precision is evaluated by repeatedly measuring samples and assessing the variability of the results against the mean measured value.
This is distinct from pathology, expert consensus, or outcomes data, which are more common for other types of medical devices.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning (e.g., for an AI algorithm). For an in vitro diagnostic assay like this, the assay is developed and optimized (which could be considered analogous to "training") using a range of samples and conditions. However, the exact sample size for this development phase is not specified in the provided summary. The data presented focuses on the validation or test set that demonstrates the final product's performance characteristics.
9. How the Ground Truth for the Training Set was Established
Since the concept of a "training set" for an AI algorithm isn't directly applicable here, the question of how its ground truth was established also doesn't fit in the conventional sense.
However, if we interpret "training" as the assay development and optimization phase, the "ground truth" during this phase would have been established through:
- Careful chemical and biological experimentation: Optimizing reagent concentrations, reaction times, and detection methods to ensure specificity and sensitivity.
- Testing against known reference samples: Using samples with accurately determined HbA1c values (via established reference methods) to fine-tune the assay's performance and calibration.
- Addressing potential interferences: Identifying and mitigating substances or conditions that could lead to inaccurate results.
This iterative process of development relies on fundamental analytical chemistry principles and validation against rigorous scientific standards rather than discrete "ground truth" labels for a set of data points as seen in AI model training.
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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: 317-521-3831
Fax: 317-521-2324
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. 2K072714 | HbA1c Gen. 3 |
|---|---|---|
| Intended Use | Whole blood applicationIn vitro test for thequantitative determination ofpercent hemoglobin A1c[HbA1c (%)] in whole bloodon Roche clinical chemistryanalyzers.Hemolysate Application:In vitro test for theQuantitative determinationof percent hemoglobin A1c[HbA1c (%)] in hemolysateprepared from whole bloodon Roche clinical chemistryanalyzers | Whole blood applicationIn vitro test for thequantitative determinationof mmol/mol hemoglobinA1c (IFCC) and %hemoglobin A1c (DCCT/NGSP) in wholeblood on Roche clinicalchemistry analyzersHemolysate ApplicationIn vitro test for thequantitative determinationof mmol/mol hemoglobinA1c (IFCC) and percenthemoglobin A1c (DCCT/NGSP) inhemolysate prepared fromwhole blood on Rocheclinical chemistryanalyzers. |
| Assay Protocol | ||
| Feature | HbA1c Gen. 2K072714 | HbA1c Gen. 3 |
| Sample Types | Whole blood/Hemolysateapplications:Anticoagulated venous orcapillary blood with thefollowing anticoagulants:Li-heparinNa-heparinK2-EDTAK3-EDTApotassium fluoride/Na2-EDTASodium fluoride/Na-EDTASodium fluoride/potassium oxalate | Whole blood/Hemolysateapplications:Anticoagulated venous orcapillary blood with thefollowing anticoagulants:Li-heparinNa-heparinK2-EDTAK3-EDTApotassium fluoride/Na2-EDTASodium fluoride/Na-EDTASodium fluoride/potassium oxalate |
| Labeled InstrumentPlatform | Integra 400/400 plusIntegra 800 | same |
| Calibrator | Cfas HbA1c | same |
| Calibration Frequency | Each lot. every 29 days. andas required following qualitycontrol procedures | same |
| Calibration mode | Logit/log 5 | Spline |
| Controls | HbA1c Control NHbA1c Control P | same |
| Reagent Stability | 2-8 °C until expiration dateon-board in use @ 8°C 28days | SameIntegra 400/400plus:on board in use @ 10-15°C28 daysIntegra 800on-board in use @ 8°C: 28days |
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| Feature | HbA1c Gen. 2K072714 | HbA1c Gen. 3 | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Measuring Range | Integra 400/400 plusHb: 4 – 35 g/dLHbA1c: 0.3 – 2.6 g/dL** Based on concentration ofthe highest standardIntegra 800Hb: 4 – 35 g/dLHbA1c: 0.3 – 3.4 g/dL* | Integra 400/400 plusHb: 4 – 40 g/dLHbA1c: sameIntegra 800Hb: 4 – 40 g/dLHbA1c: 0.3 – 2.6 g/dL | |||||||||||||||||||||
| Precision | Whole blood applicationWithin-run:0.8% @ 5.4% HbA1c0.9% @ 10.2% HbA1c | Whole blood applicationRepeatability:sample % CV %HbA1c HbA1cControl N 1.1 5.6 HbA1cControl P 0.8% 10.3 humansample 1 0.9% 4.7 humansample 2 0.8 5.8 humansample 3: 0.7 8.7 humansample 4 1.5 12.4 | |||||||||||||||||||||
| Feature | HbA1c Gen. 2K072714 | HbA1c Gen. 3 | |||||||||||||||||||||
| Precision, cont... | Whole blood application, cont...Between day1.3% @ 5.3 % HbA1c1.0% @ 10.3 % HbA1c | Whole blood application, cont...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:Within-run:1.0% @ 5.5 % HbA1c0.6% @ 10.6 % HbA1c | Hemolysate ApplicationRepeatability: | ||||||||||||||||||||||
| 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 day1.0% @ 5.3 % HbA1c0.8% @ 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. 2K072714 | HbA1c Gen. 3 |
|---|---|---|
| Analytical Sensitivity | LDLHb: 0.5 g/dLHbA1c: 0.1 g/dL | LoBHb=0.50 g/dLHbA1c: 0.19 g/dLLoDHb=1.0 g/dLHbA1c: 0.29 g/dL |
| Analytical Specificity | Hb:Labile HbA1c (pre-HbA1c).acetylated Hb. carbamylatedHb do not affect the assayresult | same |
| Hb variants:Specimens containing highamounts of HbF(> 10%)may yield lower thanexpected HbA1c results | same | |
| EndogenousInterferences | Icterus: no significantinterference | Same |
| Lipemia: no significantinterference up to atriglycerides conc of 600mg/dL ( Integra 400/400plus)and 800 mg/dL (Integra 800) | Lipemia: no significantinterference up to aIntralipid conc of 800mg/dL | |
| and 800 mg/dL (Integra 800) | same | |
| Rheumatoid factors: nosignificant interference up to750 IU/mL | same | |
| Glycemia: no significantinterference up to 1000mg/dL | ||
| Expected Values | 2.9 - 4.2 % HbA1c ( acc. toIFCC) | 29 - 42 mmol/L HbA1c(acc. IFCC) |
| 4.8 -5.9 % HbA1c (acc. toDCCT/NGSP) | same | |
| Feature | HbA1c Gen. 2K072714 | HbA1c Gen. 3 |
| Determination ofHbA1c | Turbidimetricimmunoinhibition (TINIA).Antigen-antibody complexesare formed and excess Abaggregate with polyhapten toform insoluble complexes | same |
| Determination of Hb | Bichromatic photometricdetermination afterconversion to a coloredderivate | same |
| Pretreatment | Whole blood applicationautomated on-board samplepretreatment withhemolyzing reagentHemolysate Application:Manual pretreatment withhemolyzing reagent | same |
| Antibody | Polyclonal anti-HbA1c fromsheep blood | same |
| Reporting units | % HbA1c NGSP / DCCT | mmol/mol IFCC% HbA1c NGSP/DCCT |
| Equation used for finalHbA1c value | Protocol 1 ( acc. to IFCC)$HbA1c(%)=(HbA1c/Hb)x100$Protocol 2 ( acc. to DCCT/NGSP)$HbA1c(%)=(HbA1c/Hb)x87.6+2.27$ | Protocol 1 ( acc. to IFCC)$HbA1c(mmol/mol)=(HbA1c/Hb)x1000$Protocol 2(acc. toDCCT/NGSP)$HbA1c(%)=(HbA1c/Hb)x91.5+2.15$ |
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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
§ 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).