(88 days)
No
The summary describes a turbidimetric immunoassay for measuring HbA1c, which is a standard laboratory technique and does not mention any AI or ML components.
No
This device is an in vitro diagnostic assay used to measure HbA1c, which is for monitoring long-term glucose control. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood" and that "Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus." This directly indicates its use in diagnosing or monitoring a medical condition.
No
The device description clearly states it is a "microparticle enhanced turbidimetric immunoassay," which is a laboratory test method involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro assay" and is used for the "quantitative determination of hemoglobin A1c (HbA1c) in whole blood". This clearly indicates it is used to test samples taken from the body (in vitro) to provide diagnostic information.
- Device Description: While it describes the technology (microparticle enhanced turbidimetric immunoassay), the context of its use with whole blood samples reinforces its IVD nature.
- Performance Studies: The performance studies involve testing patient samples (whole blood) and comparing the results to other established methods for measuring HbA1c. This is typical of IVD device validation.
- Predicate Devices: The listing of predicate devices (Roche Diagnostics HbA1c II and Bio-Rad VARIANT™ II) which are known IVD devices further supports that this device falls into the same category.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. The Sigma Diagnostics INFINITY™ HbA1c assay fits this definition perfectly.
N/A
Intended Use / Indications for Use
Sigma Diagnostics INFINITY™ HbAic assay is an in vitro assay for the quantitative determination of hemoglobin Are (HbAyc) in whole blood for use on automated analyzers.
Sigma Diagnostics INFINITY™ HbA ¿ is a device to measure the percent hemoglobin A. in anticoagulated whole blood. Hemoglobin A. is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.
Product codes
LCP
Device Description
The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.
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
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAz, on the Cobas Mira and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.976 and the regression equation was y = 0.9513x + 0.4184.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAg on the Cobas Mira and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.981 and the regression equation was y = 1.047x - 0.5462.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 911 and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.990 and the regression equation was y = 0.9639 + 0.5574.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbA% on the Hitachi 911 and the Bio-Rad Variant™ II Hemoglobin A%. The correlation coefficient was 0.981 and the regression equation was y = 1.046x - 0.2878.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbA1; on the Hitachi 717 and the Roche Diagnostics HbA1; II on the Hitachi 717. The correlation coefficient was 0.985 and the regression equation was y = 0.8988x + 0.9656.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 717 and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.988 and the regression equation was y = 0.9877x + 0.0711.
Key Metrics
Not Found
Predicate Device(s)
Bio-Rad VĂRIANT™ II K984268, Roche Diagnostics HbA1c II K940082
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
KOI2Y10
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter, name, address, contact 1.
Sigma Diaqnostics Inc. 545 South Ewing Ave St. Louis, MO 63103
William R. Gilbert Contact person: (314) 286-6693
July 26, 2001 Date Prepared:
2. Device name
INFINITY™ HbAic Proprietary name:
Hemoglobin Arc Common name:
Classification name: Assay, Glycosylated Hemoglobin, 81 LCP, 21 CFR 864.7470
Predicate device 3.
Roche Diagnostics HbA1c II K940082 Bio-Rad VĂRIANT™ II K984268
4. Device description
The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.
5. Intended Use
Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin Are (HbAyc) in whole blood for use on automated analyzers.
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6. Comparison to predicate devices
| Characteristic | INFINITY™ HbA1c
(Candidate Device) | Bio-Rad VARIANT™ II
(Predicate Device) | Roche Diagnostics
HbA1c II
(Predicate Device) |
|----------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the
quantitative
determination of
hemoglobin A1c (HbA1c)
in whole blood on
automated analyzers. | For use in the
quantitative
determination of
hemoglobin A1c (HbA1c)
in whole blood | For use in the
quantitative
determination of
hemoglobin A1c (HbA1c)
in whole blood on
automated analyzers. |
| Format | Microparticle enhanced
turbidimetric
immunoassay | Cation exchange
chromatography (HPLC) | Immunoturbidimetric |
| Sample Type | Human anticoagulated
whole blood (EDTA or
Heparin) | Human anticoagulated
whole blood (EDTA) | Human anticoagulated
whole blood (EDTA or
Heparin) |
The substantial equivalency of Sigma Diagnostics INFINITY™ HbAy (537-A, 537-B) to the Roche Diagnostics HbAre II and to the Bio-Rad Variant™ II Hemoglobin A1c, is supported by the following facts:
-
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAz, on the Cobas Mira and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.976 and the regression equation was y = 0.9513x + 0.4184.
-
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAg on the Cobas Mira and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.981 and the regression equation was y = 1.047x - 0.5462.
- . 3. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 911 and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.990 and the regression equation was y = 0.9639 + 0.5574.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics 4. INFINITY™ HbA% on the Hitachi 911 and the Bio-Rad Variant™ II Hemoglobin A%. The correlation coefficient was 0.981 and the regression equation was y = 1.046x - 0.2878.
- ട. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbA1; on the Hitachi 717 and the Roche Diagnostics HbA1; II on the Hitachi 717. The correlation coefficient was 0.985 and the regression equation was y = 0.8988x + 0.9656.
-
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 717 and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.988 and the regression equation was y = 0.9877x + 0.0711.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics, Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
OCT 2 6 2001
Re: K012410
Trade Name: Sigma Diagnostics INFINITY™ HbA1c Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated Hemoglobin Regulatory Class: II Product Code: LCP Dated: July 27, 2001 Received: July 30, 2001
Dear Dr. Gilbert:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ KOLQH IQ
Device Name: Sigma Diagnostics INFINITY™ HbA1c
Indications For Use:
Sigma Diagnostics INFINITY™ HbA ¿ is a device to measure the percent hemoglobin A . in anticoagulated whole blood. Hemoglobin A . is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.
Sglite Mohine O for J. BAUTISTA
Division of Clinical Laboratory Devices
012410 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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