(324 days)
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No
The summary describes a standard immunoassay and spectrophotometric method for measuring HbA1c, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic reagent system used for quantitative determination of hemoglobin A1c, which is a diagnostic purpose rather than a therapeutic one. It monitors blood glucose control but does not treat or alleviate a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro diagnostic reagent system" and that "HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus," which is a diagnostic purpose.
No
The device is an in vitro diagnostic reagent system, which involves chemical reagents and is used on clinical chemistry analyzers, indicating it is a hardware and reagent-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro diagnostic reagent system."
- Purpose: The assay is designed for the "quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood." This is a test performed on biological samples outside of the body to provide information for medical diagnosis or monitoring.
- Device Description: The description details a laboratory-based test using a turbidimetric inhibition immunoassay (TINIA) on clinical chemistry analyzers, which is characteristic of IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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. 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.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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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).
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§ 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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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 Diagnostics | ||||
| 9115 Hague Road | |||||
| PO Box 50416 | |||||
| Indianapolis, IN 46250 | |||||
| Phone: 317-521-3380 | |||||
| Fax: 317-521-2324 | |||||
| Contact person: Susan Hollandbeck | |||||
| Email: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 assay | ||||
| Common name: HbA1c Gen.2 | |||||
| Classification name: Glycosylated Hemoglobin assay | |||||
| Product 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 application
In vitro test for the quantitative
determination of percent
hemoglobin A1c [HbA1c (%)]
in whole blood on Roche
clinical chemistry analyzers | Whole blood application
In vitro test for the quantitative
determination of mmol/mol
hemoglobin Alc (IFCC) and %
hemoglobin Alc
(DCCT/NGSP) 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 | Hemolysate Application
In vitro test for the quantitative
determination of mmol/mol
hemoglobin A1c (IFCC) and
% hemoglobin Alc
(DCCT/NGSP) in hemolysate
prepared from whole blood on
Roche clinical chemistry
analyzers |
| Sample Types | Anticoagulated venous or capillary
blood
Acceptable anticoagulants for both | Anticoagulated venous or
capillary blood
Acceptable anticoagulants for both |
| | the hemolysate and whole blood
applications include
• Li-heparin
• K2-EDTA
• K3-EDTA
• KF/Na2-EDTA | the hemolysate and whole blood
applications include
• Li-Heparin
• K2-EDTA
• K3-EDTA
• KF/Na2-EDTA |
| | | Acceptable anticoagulants for the
hemolysate application include
• Na-Heparin
• NaF/K-Oxalate |
| Feature | Predicate Device: | Candidate Device: |
| | HbA1c Gen. 2 (K072714) | HbA1c Gen. 2 |
| Instrument
Platform | Integra 400/400 plus
Integra 800 and Integra 800 CTS
(Closed Tube system) | same |
| Calibrator | Cfas HbAlc | same |
| Calibration
Frequency | Each lot, every 29 days, and as
required following quality control
procedures | same |
| Calibration
Mode | Logit/log 5 | same |
| Controls | HbAlc Control N
HbAlc Control P | HbAlc Control N
HbA1c Control P
PreciControl HbAlc norm
and path (cleared in K103099) |
| Reagent
Stability | Unopened
2-8 °C until expiration date
On-board in use
Integra 400/400plus
10-15°C for 28 days
Integra 800
8°C for 28 days | same |
| 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. This test range is
based on a typical calibrator value
of 2.6 g/dL.
Integra 800
Hb: 4 – 35 g/dL
HbAlc: 0.3 – 3.4 g/dL | same |
| Reporting Units | % HbAlc NGSP / DCCT | % HbAlc NGSP/DCCT and
mmol/mol IFCC |
| Antibody | Polyclonal anti-HbA1c from sheep
blood | same |
| Feature | Predicate Device:
HbA1c Gen. 2 (K072714) | Candidate Device:
HbA1c Gen. 2 |
| 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 | Change in nomenclature:
"Within-run" is now called
"Repeatability" and "Between day
is now called "Intermediate
precision." |
| | Between day:
1.0 % @ 5.3 % HbA1c
0.8% @ 10.7 % HbA1c | |
| | | |
| Expected
Values | Protocol 1
2.9 – 4.2 % HbA1c
(acc. to IFCC) | Protocol 1
29 – 42 mmol/mol HbA1c
(acc. IFCC) |
| | Protocol 2
4.8 -5.9 % HbA1c
(acc. to DCCT/NGSP) | Protocol 2
same |
| | | |
| 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 derivate | same |
| Pretreatment | Whole blood application
automated on-board sample
pretreatment with hemolyzing
reagent | same |
| | Hemolysate Application: | |
| | Manual pretreatment with | |
| | hemolyzing reagent | |
| Feature | Predicate Device:
HbA1c Gen. 2 (K072714) | Candidate Device:
HbA1c Gen. 2 |
| Analytical
Sensitivity | LDL
Hb: 0.5 g/dL
HbA1c: 0.1 g/dL | LOB and LOD
Hb:
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) |
| Analytical
Specificity | Hb derivates:
Labile HbA1c (pre-HbA1c),
acetylated Hb, carbamylated Hb
do not affect the assay result
Hb variants:
Specimens containing high
amounts of HbF (> 10 %) may
yield lower than expected HbA1c
results | same |
| Endogenous
Interferences | Icterus
no significant interference
Rheumatoid factors
no significant interference up to
750 IU/mL
Glycemia
no significant interference up to
1000 mg/dL
Lipemia
Integra 400/400 plus analyzers:
No significant interference up to a
triglycerides concentration of 600
mg/dL
Integra 800 analyzer:
No significant interference up to a
triglycerides concentration of 800
mg/dL | same |
3
Substantial equivalence (continued)
4
Substantial equivalence (continued)
5
Substantial equivalence (continued)
6
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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Page 2
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