(62 days)
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No
The provided text describes a laboratory assay for measuring homocysteine levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical reagents and their intended use for quantitative determination.
No
This device is for in-vitro diagnostic use, specifically for the quantitative determination of homocysteine in serum or plasma to assist in diagnosis, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone" and is "For in-vitro diagnostic use only."
No
The device is an in-vitro diagnostic reagent assay, which is a chemical product used to perform tests on biological samples. This is a physical product, not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only." and "Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only."
- Purpose: The intended use describes the device as being used to measure a substance (total L-homocysteine) in a sample taken from the body (serum or plasma) for the purpose of assisting in the diagnosis and treatment of patients. This is the core definition of an in vitro diagnostic device.
The text explicitly uses the term "in vitro diagnostic use only" and describes the device's function as a quantitative determination of a substance in a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.
Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JIX
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diazyme Laboratories c/o Mr. Charles Lu Quality System Manager 12889 Gregg Court Poway, CA 92064
SEP 1 7 2007
K071971 Re:
Trade Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay Regulation Number: 21 CFR 8862.1377 Regulation Name: Urinary Homocysteine (nonquantiative) test system Regulatory Class: Class II Product Code: LPS, JIX Dated: August 20, 2007 Received: August 21, 2007
Dear Mr. Lu:
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 10(x) marketed predicate device results in a classification for your device and than bernetted 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) 276-0490. 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 une (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
2
Indications for Use
510(k) Number (if known):
Image /page/2/Picture/3 description: The image shows a handwritten text string that appears to be "K07 1971". The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The text is clear and legible against the plain background.
Device Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay
Indications for Use: Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.
Device Name: Diazyme Homocysteine Calibrators
Indications for Use: Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 13 sion Sign-C
ିffice of In Vitro Diagnostic Device I Waluation and Safety
K07/971