(541 days)
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No
The description focuses on a reagent-based immunological assay and a simple calculation, with no mention of AI/ML terms or functionalities.
No
The device is an in vitro diagnostic reagent used for monitoring long-term glucose control and does not provide therapeutic treatment.
Yes
The device is described as an "In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood," and its measurements are "effective in monitoring long term glucose control in individuals with diabetes mellitus," indicating its use in diagnosing or monitoring health conditions.
No
The device is described as an In Vitro Diagnostic reagent test kit, which includes physical components like reagents, calibrators, and controls, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent..."
- Definition of IVD: An IVD is a medical device used to examine specimens taken from the human body, such as blood, for the purpose of providing information for diagnosis, monitoring, or screening. This device analyzes human whole blood to determine HbA1c levels, which is used for monitoring long-term glucose control in individuals with diabetes mellitus. This aligns perfectly with the definition of an IVD.
- Components: The kit includes reagents, calibrators, and controls, which are typical components of an IVD test kit.
N/A
Intended Use / Indications for Use
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in the human whole blood. The concentration of HbA1c is determined using an immunological assay. Both the concentration of HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application has been validated for the Hitachi instrument of clinical chemistry by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.
Product codes
LCP, KRZ, JJX
Device Description
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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.
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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
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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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with healthcare and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 5 2004
Paul Anand, Ph.D. Director BioDiagnostic International 615 North Berry St. # E Brea, CA 92821
K031296 Re: Trade/Device Name: LIQUI-HEME Glycohemoglobin A1c Assay LIQUI-HEME Hemoglobin Alc Control Set LIQUI-HEME Hemoglobin Alc Calibrators Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ, JJX Dated: October 1, 2004 Received: October 4, 2004
Dear Dr. Anand:
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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, U.S. DVM.
Jean M. Cooper, MS, D.V.M. 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): K031296
Device Name: LIQUI-HEME Glycohemoglobin A1c Assay
Indications For Use:
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro The DioDiagnostic reagent for the Styconomission of Glycohemoglobin A1c (HbA1c)
Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) Diagnostic reagent for the quarklained is an immunological assay. Both the in the numan whole blood. The momentration of the total hemoglobin are measured. Concentration of The and the culated as a percentage of the total hemoglobin concentration.
concentration.
Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Control in Individuals with diaboted for the Hitachi instrument of clinical This application onoot has been by suitably qualified personnel under appropriate clinical laboratory conditions.
Cillifical laboratory conditions:
Further ,this test kit also includes a set of six calibrators and bilevel(Human) Low and High controls, which are optional.
Prescription Use __ V (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)
Albert S
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) _k031296