Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a turbidimetric inhibition immunoassay and standard chemical analysis calculations, with no mention of AI or ML terms or processes.

Therapeutic

No
This device is for the quantitative determination of percent hemoglobin A1c, which is a diagnostic tool for monitoring diabetes, not a therapeutic intervention itself.

Diagnostic

Yes
Explanation: The device is used for the "quantitative determination of percent hemoglobin A1c" which is useful for "monitoring of long-term blood glucose control in individuals with diabetes mellitus." This information is used for diagnosis, management, or treatment of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "test system" that uses a "turbidimetric inhibition immunoassay (TINIA)" and involves the preparation of a "hemolyzed sample" from "anticoagulated whole blood". This indicates the use of physical reagents and laboratory procedures, which are hardware components and processes, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states it's for the "quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood)". This involves testing a sample taken from the body (whole blood) in vitro (outside the body) to provide information about a medical condition (monitoring blood glucose control in individuals with diabetes mellitus).
Device Description: The description details a "turbidimetric inhibition immunoassay (TINIA)" performed on a "hemolyzed sample". This is a laboratory-based test method applied to a biological specimen.
Sample Type: The input is "whole blood (or hemolysate derived from whole blood)", which is a biological specimen.

These characteristics align directly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Tina-Quant Hemoglobin A1c Gen.2 test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of percent hemoglobin A1c in hemolysate or whole blood. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

For the quantitative determination of percent hemoglobin Alc in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers.

HbAlc 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.2 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

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

Precision:
Whole blood application:
Within run:
0.8% @ 5.4% HbA1c
0.9% @ 10.2% HbA1c
Between day:
1.3% @ 5.3% HbA1c
1.0% @ 10.3% HbA1c

Hemolysate application
Within run:
1.0% @ 5.5% HbA1c
0.6% @ 10.6% HbA1c
Between day:
1.0% @ 5.3% HbA1c
0.8% @ 10.7% HbA1c

Lower detection limit: 0.02 g/dL HbA1c, 0.09 g/dL Hb

Endogenous interferences (Whole blood application): No significant interference from: Icterus, Lipemia: up to 800 mg/dL Intralipid, Rheumatoid factor: up to 750 IU/mL, Glycemia: up to 1000 mg/dL glucose.
No significant interference (bias within +/- 10%) up to: 800 mg/dL Intralipid, 30 mg/dL Bilirubin/ditaurobilirubin, 350 IU/mL RF, 1000 mg/dL Glucose.

Expected values: 2.9-4.2% HbA1c. Based on study done with IFCC standardization.

Specificity: No cross reaction with HbAo, HbAla, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, glycated albumin and labile HbA1c were found for the anti-HbA1c antibodies used in this kit. Specimens containing high amounts of HbF (>10%) may yield lower than expected HbA1c results. Specificity claims transferred from predicate Tina-Quant HbA1c device.

Anticoagulant: Both reagent-specific and general criteria apply (based on NGSP values).
Reagent-specific criteria: Mean deviation of all samples:

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

K072714

APR 1 8 2008

510(k) Summary – Tina-Quant® Hemoglobin A1c Gen.2

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence

Submitter name, address, contact

Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723

Contact person: Tracy Bush

Oct 15, 2007 Date prepared:

Submission Purpose and History

The Tina-Quant Hemoglobin A 1c Gen.2 assay was originally cleared for use as K052464. The purpose of this submission is to modify the device by extending the labeled measuring range for the HbA Ic portion of the %HbAlc measurement in the application for Integra 800 analyzers.

Since the clearance of K052464, a number of changes have taken place to the device, for which an additional filing was not deemed necessary. We hereby provide notification of these changes:

. Inclusion of additional anticoagulant type (potassium fluoride/ Na2-EDTA) in the Specimen Collection and Preparation section of the labeling (supported via internally documented data)
Device Name

Proprictary name: Tina-Quant® Hemoglobin A1c Gen.2 test

Common name: Hemoglobin A1c test

Classification name: Glycosylated hemoglobin assay

1

| 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 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.2 test is in vitro diagnostic reagent
system intended for use on the COBAS INTEGRA 800 analyzers for the
quantitative determination of percent hemoglobin A1c in hemolysate or
whole blood. 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 ® Hemoglobin A1c
Gen.2 cleared as K052464. |
| Substantial
equivalency –
Similarities | The table below indicates the similarities between the modified Tina-Quant ®
Hemoglobin A1c Gen.2 test and its predicate device (original Tina-Quant®
Hemoglobin A1c Gen.2, K052464). |

:

| Feature | Predicate: Tina-Quant ®
Hemoglobin A1c Gen.2 (K052464) | Modified device: Tina-Quant
HbA1c Gen.2 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/
Indications for
Use | For the quantitative determination of
percent hemoglobin A1c in whole
blood (or hemolysate derived from
whole blood) on COBAS Integra
800 anlayzers. HbA1c
determinations are useful for
monitoring of long-term blood
glucose control in individuals with
diabetes mellitus. | For the quantitative determination
of percent hemoglobin A1c in
whole blood (or hemolysate derived
from whole blood) on Roche
clinical chemistry analyzers. |
| Indications for
Use | HbA1c determinations are useful for
monitoring of long-term blood
glucose control in individuals with
diabetes mellitus. | HbA1c determinations are useful
for monitoring of long-term blood
glucose control in individuals with
diabetes mellitus. |

2

| Specimen type | Anticoagulated venous or capillary
blood. Acceptable anticoagulants in
clude Li-heparin, K2-EDTA, K3-
EDTA | Anticoagulated venous or capillary
blood. Acceptable anticoagulants in
clude Li-heparin, K2-EDTA, K3-
EDTA and potassium fluoride/Na2-
EDTA |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument
platform | Integra 800 analyzer | Integra family including Integra
400/400 plus, 800, 800 CTS
(Closed Tube Sampling), cobas
c111; also cobas c501 |
| Test principle | | |
| Determination of
HbA1c | Turbidimetric immunoinhibition
(TINIA). Antigen-antibody
complexes are formed and excess
Ab aggregate with polyhapten to
form insoluble complexes. | Same |
| Determination of
Hb | Bichromatic photometric
determination after conversion to a
colored derivative.
Hb is measured in same channel
during preincubation phase of
HbA1c determination (sample +
R1). | Same. |
| Calculation of %
HbA1c | % HbA1c is calculated
automatically by instrument
according to user-selected protocol | Same |
| Pretreatment | Two options for pretreatment:

Hemolysate application:
same (Manual pretreatment with
hemolyzing reagent)

8ug/mL; Stabilizers | Same |
| Hemolyzing
reagent | Different concentrations used | Same |
| | Hemolysate application:
Uses separate hemolyzing reagent
with 20 mM EDTA | |
| | Whole blood application:
Uses Hemolyzing reagent Gen.2 –
fourfold increase in concentration | |
| Reagent stability | 2-8 °C until expiration date
On-board: 28 days | Same |
| Performance characteristics (Integra) | | |
| Precision | Whole blood application:
Within run:
0.8% @ 5.4% HbA1c
0.9% @ 10.2% HbA1c | Same |
| | Between day:
1.3% @ 5.3% HbA1c
1.0% @ 10.3% HbA1c | |
| | Hemolysate application
Within run:
1.0% @ 5.5% HbA1c
0.6% @ 10.6% HbA1c | |
| | Between day:
1.0% @ 5.3% HbA1c
0.8% @ 10.7% HbA1c | |
| | | |
| Lower detection
limit | 0.02 g/dL HbA1c
0.09 g/dL Hb | Same |
| Endogenous
interferences | Whole blood application:
No significant interference from:
Icterus | Same |
| | Lipemia: up to 800 mg/dL Intralipid | |
| | Rheumatoid factor: up to 750 IU/mL | |
| | Glycemia: up to 1000 mg/dL glucose | |
| | | |
| Expected values | 2.9-4.2% HbA1c
Based on study done with IFCC
standardization | Same |
| Specificity | No cross reaction with HbAo,
HbAla, HbA1b, acetylated
hemoglobin, carbamylated
hemoglobin, glycated albumin and
labile HbA1c were found for the
anti-HbA1c antibodies used in this
kit.
Specimens containing high amounts
of HbF (>10%) may yield lower than
expected HbA1c results. | Same |

and the control control of the control of

:

、

·

3

:

.

4

Substantial The table below indicates the differences between the modified Tina-Quant ® equivalency --Hemoglobin A 1c Gen.2 test and its predicate device (original Tina-Quant ® Differences Hemoglobin A1c Gen.2, K052464).

| Feature | Predicate: Tina-Quant ®
Hemoglobin A1c Gen.2 (K052464) | Modified device: Tina-Quant
HbA1c Gen.2 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Specimen type | Anticoagulated venous or capillary
blood. Acceptable anticoagulants in
clude Li-heparin, K2-EDTA, K3-
EDTA | Anticoagulated venous or capillary
blood. Acceptable anticoagulants in
clude Li-heparin, K2-EDTA, K3-
EDTA and potassium fluoride/Na2-
EDTA |
| Instrument
platform | Integra 800 analyzer | Integra family including Integra
400/400 plus, 800, 800 CTS
(Closed Tube Sampling), cobas
c111; also cobas c501 |
| Performance Characteristics (Integra) | | |
| Measuring
Range | 0.3-2.6 g/dL HbAlc*
4-35 g/dL Hb
*Based on concentration of the
highest standard | Integra 400/400 plus:
same
Integra 800/ 800 CTS:
0.3 - 3.4 g/dL HbA1c
4-35 g/dL Hb |

5

| Endogenous interferences
(whole blood application
only) | Analyte recovery in presence
of interfering agent. Tested
for:
Lipemia (Intralipid) Bilirubin (conjugated
and unconjugated) Rheumatoid Factor Glucose | No significant interference
(bias within ± 10%) up to:
800 mg/dL Intralipid 30 mg/dL Bilirubin/
ditaurobilirubin 350 IU/mL RF 1000 mg/dL Glucose |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anticoagulant | Testing of ≥ 50 paired samples
(i.e. serum/plasma) | Both reagent-specific and
general criteria apply
(based on NGSP values)
Reagent-specific criteria Mean deviation of all
samples: