(22 days)
Not Found
No
The summary describes a standard immunoassay for HbA1c and does not mention any AI or ML components. The calculation of % HbA1c is based on a ratio and a user-selected protocol, not an AI/ML algorithm.
No
This device is an in vitro diagnostic reagent system used for the quantitative determination of hemoglobin A1c to monitor long-term blood glucose control. It does not directly treat or prevent a disease.
No
The device is described as an "in vitro diagnostic reagent system," meaning it is a component used for diagnostic testing, not the diagnostic device itself.
No
The device description clearly outlines a reagent system and a process involving physical samples (whole blood), chemical reactions (hemolysis, immunoassay), and measurement using an instrument, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Tina-Quant Hemoglobin A1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin A 1c in whole blood."
This statement directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Tina-Quant Hemoglobin A 1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin Alc in whole blood. HbA1c results 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 A 1 c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA 1c 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 % HbA lc from the HbA 1c/ 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
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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% @ 55% HbA1c
0.6% @ 10.6% HbA1c
Between day:
1.0% @ 5.3% HbA1c
0.8% @ 10.7% HbA1c
Linearity:
0.3-2.6 g/dL HbA1c
4-35 g/dL Hb
(Based on highest calibrator value)
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
Expected values:
2.9-4.2% HbA1c
Based on study done with IFCC standardization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
§ 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).
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SEP 3 0 2005
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: Theresa M. Ambrose | |
| Date prepared: Sept 7, 2005 | |
| Device Name | Proprietary name: Tina-Quant® Hemoglobin A1c Gen.2 test |
| Common name: Hemoglobin A1c test | |
| Classification name: Glycosylated hemoglobin assay | |
| Device Description | With the Tina-Quant Hemoglobin A 1 c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA 1c 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 % HbA lc from the HbA 1c/ Hb ratio according to a user selected protocol. |
| Intended use | The Tina-Quant Hemoglobin A 1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin Alc in whole blood. |
| HbA1c results 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 cleared as K934070. |
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The table below indicates the similarities between the modified Tina-Quant ® Substantial equivalency -Hemoglobin A1c Gen.2 test and its predicate device (original Tina-Quant ® Similarities Hemoglobin, K934070).
| Feature | Predicate device: original Tina-
Quant HbAlc
(K934070) | Modified device: Tina-Quant
HbAlc Gen.2 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/
Indications for
Use | For the quantitative determination of
hemoglobin Alc in whole blood.
From summary: Measurements are
useful to provide an indication of
glycemic control in patients with
diabetes mellitus. | The Tina-Quant Hemoglobin Alc
Gen.2 test is an in vitro diagnostic
reagent system intended for the
quantitative determination of
percent hemoglobin Alc in whole
blood.
HbA1c results are useful for
monitoring of long-term blood
glucose control in individuals with
diabetes mellitus |
| Specimen type | Capillary blood;EDTA or
heparinized whole blood. | Same |
| Test principle | | |
| Determination of
HbAlc | 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. | Same. |
| Calculation of %
HbAlc | % HbAlc is calculated
automatically by instrument
according to user-selected protocol | Same |
| Reagent information | | |
| Hemolyzing
reagent: sample
ratio | 1:100 | Same |
| Antibody | Polyclonal anti-HbAlc from sheep
blood | Same antibody. |
| Calibrator | Hemolysate derived from human
blood and sheep blood; TTAB
detergent; stabilizer. | Same |
| Quality control | Precinorm HbAlc
Precipath HbAlc | Same |
| Performance characteristics | | |
| Specificity | No cross-reactivity with HbAo, HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, glycated albumin, labile HbA1c and HbA1d and an acetaldehyde hemoglobin adduct. | Stability claims transferred from predicate device due to use of same antibody and similar reagent: sample ratio. |
F ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2
The table below indicates the differences between the modified Tina-Quant ® Substantial equivalency -Hemoglobin A 1 c Gen.2 test and its predicate device (original Tina-Quant ® Differences Hemoglobin, K934070).
| Feature | Predicate device: original Tina-
Quant HbA1c
(K934070) | Modified device: Tina-Quant
HbA1c Gen.2 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pretreatment | Manual pretreatment with
hemolyzing reagent | Two options for pretreatment:
Hemolysate application:
same (Manual pretreatment with
hemolyzing reagent)
Whole blood application:
automated on-board sample
pretreatment with hemolyzing
reagent |
| Instruments | Automated analyzers including
Hitachi family | Integra 800 |
| Determination of
Hb | Occurs in separate channel with
separate reagent. | Hb is measured in same channel
during preincubation phase of
HbA1c determination (sample +
R1). No separate reagent or channel
needed. |
| R1 | Buffer: 50 mM MES, pH6.2
Antibody; stabilizers | Buffer: 25 mM MES/ 15 mM TRIS
pH 6.2
Antibody; stabilizers |
| R2 | Buffer: 50 mM MES, pH 6.2;
Polyhapten modified with
aminodextran AD50; concentration
20 ug/mL
Stabilizers | Buffer: 25 mM MES/15mM Tris,
ph 6.2;
Polyhapten modified with
aminodextran AD500;
concentration > 8ug/mL; Stabilizers |
| Hemolyzing
reagent | Contains 10 mM EDTA and TTAB
detergent | Different concentrations used |
| | | Hemolysate application:
Uses separate hemolyzing reagent
with 20 mM EDTA |
| | | Whole blood application:
Uses Hemolyzing reagent Gen.2 –
fourfold increase in concentration
No separate reagent needed. |
| Hb reagent | Phosphate buffer 20 mM, pH 7.4;
stabilizers | |
| Calibrator | Provided with kit as lyophilisate in
four levels. | Provided separately as single level;
diluted on-board the analyzer. |
| Traceability | In-house reference materials | Standardized against approved
IFCC reference method |
| Reagent stability | 2-8 °C until expiration date
opened: 4 weeks at 2-12 °C | 2-8 °C until expiration date
On-board: 28 days |
| Precision | Within run:
3.8% @ 5.2% HbA1c
4.0% @ 11.3% HbA1c
Total:
5.8% @ 5.2% HbA1c
5.6% @ 11.3% HbA1c | 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% @ 55% HbA1c
0.6% @ 10.6% HbA1c
Between day:
1.0% @ 5.3% HbA1c
0.8% @ 10.7% HbA1c |
| Linearity | 0.3 g/dL up to highest calibrator for
HbA1c.
9-24 g/dL Hb
(before dilution) | 0.3-2.6 g/dL HbA1c
4-35 g/dL Hb
(before dilution)
(Based on highest calibrator value) |
| Lower detection
limit | 0.3 g/dL HbA1c | 0.02 g/dL HbA1c
0.09 g/dL Hb |
| Endogenous
interferences | No interference from Acetylsalicylic
acid; Gamma globulin; Rheumatoid
factor or ascorbic acid | Whole blood application:
No significant interference from:
Icterus |
| | Lipemia up to 17.5 mg/dL | Lipemia: up to 800 mg/dL |
| | Lipemia (intralipid) up to 1230 mg/dL | Intralipid |
| | | Rheumatoid factor: up to 750
IU/mL |
| | | Glycemia: up to 1000 mg/dL
glucose |
| Expected values | 4.3% - 5.8% HbA1c
Based on 1993 study with in-house
standardization | 2.9-4.2% HbA1c
Based on study done with IFCC
standardization |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
SEP 3 0 2005
Ms. Theresa Ambrose Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
Re: K052464
Trade/Device Name: Tina-Quant® Hemoglobin A1c Gen.2 Test Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 07, 2005 Received: September 08, 2005
Dear Ms. Ambrose:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 –
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting 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
510(k) Number (if known): K052464
Device Name: Tina-Quant® Hemoglobin A1c Gen.II
Indications For Use:
The Tina-Quant Hemoglobin A1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin A 1c in whole blood. HbAlc results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of
Office In Vitro Diagnostic Device Evaluation and Safety
510(k) K052464