Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay and spectrophotometric method for measuring HbA1c, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
This device is an in vitro diagnostic reagent system used to quantify hemoglobin A1c, which is used for monitoring blood glucose control in individuals with diabetes. It is a diagnostic tool, not a therapeutic one.

Diagnostic

Yes

The document explicitly states in the "Intended Use / Indications for Use" section that "The Tina-Quant Hemoglobin A1c Gen. test is in vitro diagnostic reagent system".

SaMD (Software as a Medical Device)

No

The device is described as an in vitro diagnostic reagent system intended for use on specific analyzers, involving a turbidimetric inhibition immunoassay and measurement of absorption spectrum, indicating it is a physical reagent and requires hardware (the analyzer) for operation.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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."

This statement clearly identifies the device as an in vitro diagnostic reagent system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The document provides comparative performance data between the HbA1c Gen. 2 and HbA1c Gen. 3 assays for various features:

Measuring Range:
- Integra 400/400 plus: Hb: 4 – 40 g/dL, HbA1c: 0.3 – 2.6 g/dL
- Integra 800: Hb: 4 – 40 g/dL, HbA1c: 0.3 – 2.6 g/dL
Precision:
- Whole blood application:
  - Repeatability:
    - HbA1c Control N: 1.1% CV at 5.6% HbA1c
    - HbA1c Control P: 0.8% CV at 10.3% HbA1c
    - Human sample 1: 0.9% CV at 4.7% HbA1c
    - Human sample 2: 0.8% CV at 5.8% HbA1c
    - Human sample 3: 0.7% CV at 8.7% HbA1c
    - Human sample 4: 1.5% CV at 12.4% HbA1c
  - Intermediate precision:
    - HbA1c Control N: 1.3% CV at 5.6% HbA1c
    - HbA1c Control P: 0.9% CV at 10.3% HbA1c
    - Human sample 1: 1.1% CV at 4.7% HbA1c
    - Human sample 2: 1.1% CV at 5.8% HbA1c
    - Human sample 3: 0.8% CV at 8.7% HbA1c
    - Human sample 4: 1.6% CV at 12.4% HbA1c
- Hemolysate Application:
  - Repeatability:
    - HbA1c Control N: 0.9% CV at 5.6% HbA1c
    - HbA1c Control P: 0.9% CV at 10.1% HbA1c
    - Human sample 1: 1.0% CV at 4.7% HbA1c
    - Human sample 2: 0.9% CV at 5.8% HbA1c
    - Human sample 3: 0.8% CV at 8.7% HbA1c
    - Human sample 4: 1.2% CV at 12.0% HbA1c
  - Intermediate precision:
    - HbA1c Control N: 1.3% CV at 5.6% HbA1c
    - HbA1c Control P: 0.9% CV at 10.1% HbA1c
    - Human sample 1: 1.2% CV at 4.7% HbA1c
    - Human sample 2: 1.0% CV at 5.8% HbA1c
    - Human sample 3: 0.9% CV at 8.7% HbA1c
    - Human sample 4: 1.5% CV at 12.0% HbA1c
Analytical Sensitivity:
- LoB: Hb=0.50 g/dL, HbA1c: 0.19 g/dL
- LoD: Hb=1.0 g/dL, HbA1c: 0.29 g/dL
Analytical Specificity: Same as predicate device. Labile HbA1c, acetylated Hb, carbamylated Hb do not affect assay result. Hb variants (HbF > 10%) may yield lower than expected results.
Endogenous Interferences:
- Icterus: no significant interference.
- Lipemia: no significant interference up to an Intralipid conc of 800 mg/dL.
- Rheumatoid factors: no significant interference up to 750 IU/mL.
- Glycemia: no significant interference up to 1000 mg/dL.
Expected Values: 29 - 42 mmol/L HbA1c (acc. IFCC), 4.8 - 5.9 % HbA1c (acc. DCCT/NGSP).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for sensitivity and precision metrics.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072714

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

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
K072714 | HbA1c Gen. 3 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Whole blood application
In vitro test for the
quantitative determination of
percent hemoglobin A1c
[HbA1c (%)] in whole blood
on Roche clinical chemistry
analyzers
.
Hemolysate Application:
In vitro test for the
Quantitative determination
of percent hemoglobin A1c
[HbA1c (%)] in hemolysate
prepared from whole blood
on Roche clinical chemistry
analyzers | Whole blood application
In vitro test for the
quantitative determination
of mmol/mol hemoglobin
A1c (IFCC) and %
hemoglobin A1c (
DCCT/NGSP) in whole
blood on Roche clinical
chemistry analyzers

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

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・

.

3

| Feature | HbA1c Gen. 2
K072714 | HbA1c Gen. 3 | | | | | | | | | | | | | | | | | | | | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Measuring Range | Integra 400/400 plus
Hb: 4 – 35 g/dL
HbA1c: 0.3 – 2.6 g/dL*

Based on concentration of
the highest standard

Integra 800
Hb: 4 – 35 g/dL
HbA1c: 0.3 – 3.4 g/dL* | Integra 400/400 plus
Hb: 4 – 40 g/dL
HbA1c: same

0.8% @ 5.4% HbA1c
0.9% @ 10.2% HbA1c | Whole blood application
Repeatability:
sample % CV %HbA1c HbA1c
Control N 1.1 5.6 HbA1c
Control P 0.8% 10.3 human
sample 1 0.9% 4.7 human
sample 2 0.8 5.8 human
sample 3: 0.7 8.7 human
sample 4 1.5 12.4 | | | | | | | | | | | | | | | | | | | | | |
| Feature | HbA1c Gen. 2
K072714 | HbA1c Gen. 3 | | | | | | | | | | | | | | | | | | | | | |
| Precision, cont... | Whole blood application, cont...

Between day
1.3% @ 5.3 % HbA1c
1.0% @ 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 % HbA1c
0.6% @ 10.6 % HbA1c | Hemolysate Application
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
1.0% @ 5.3 % HbA1c
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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:

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5

| Feature | HbA1c Gen. 2
K072714 | HbA1c Gen. 3 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Analytical Sensitivity | LDL
Hb: 0.5 g/dL
HbA1c: 0.1 g/dL | LoB
Hb=0.50 g/dL
HbA1c: 0.19 g/dL

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).

8

Page 2 -

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

9

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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