(50 days)
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No
The summary describes a standard enzymatic assay for measuring homocysteine levels and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative determination of homocysteine levels, which assists in diagnosis and treatment, but it does not directly provide therapy.
Yes
The device is intended for the quantitative determination of total L-homocysteine in serum and heparin plasma to assist in the diagnosis and treatment of patients with suspected hyperhomocysteinemia and homocystinuria.
No
The device is an in vitro diagnostic (IVD) assay kit, which inherently involves chemical reagents and likely hardware components (e.g., spectrophotometer or analyzer) for measurement, not just software. The description focuses on the assay's intended use and components (reagents, calibrator, controls), not software functionality.
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 "intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma." The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the living body.
- Purpose: The intended use also states that the reagents "can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria." This clearly indicates a medical purpose related to diagnosis and patient management.
- Sample Type: The assay is designed to test "serum and heparin plasma," which are biological samples commonly used in laboratory diagnostics.
- Components: The description mentions a calibrator and controls, which are standard components of diagnostic assay kits used for accurate measurement and quality control.
- Regulatory Classification: The "Intended User / Care Setting" mentions "Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)". While the specific classification isn't fully detailed, being subject to these regulations indicates it's a medical device intended for diagnostic purposes.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria.
Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.
Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.
Product codes
LPS, 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines that form a stylized bird-like shape, representing health and well-being. The overall design is simple and professional, reflecting the department's role in public health and human services.
OCT 2 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121
Re: K042448
Trade/Device Name: Diazyme Homocysteine Enzymatic Assay Kit Diazyme Homocysteine Controls Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS, JJX Dated: September 7, 2004 Received: September 9, 2004
Dear Mr. Tran:
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,
Seain M. Corgan MS, 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:
Device Name: Diazyme Homocysteine Enzymatic Assay Kit
Indications for Use:
Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can in diagnosis and treatment of patients suspected in having assist hyperhomocysteinemia and homocystinuria.
Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.
Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.
Prescription Use (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)
Alberto
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042448