(65 days)
Not Found
No
The description details a biochemical assay based on enzymatic reactions and protein binding, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: The device is an in-vitro diagnostic assay used for quantitative determination of homocysteine, assisting in diagnosis. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This directly indicates its role in diagnosis.
No
The device description clearly outlines a laboratory assay involving reagents, sample pretreatment, and a microplate format, indicating a hardware-dependent chemical process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of total L-homocysteine in human serum or plasma." This is a test performed on biological samples in vitro (outside the body).
- Device Description: The description details an "EIA-like assay" that uses reagents and a microplate format to analyze blood samples. This is a typical setup for an in vitro diagnostic test.
- Specimen Type: The assay uses "human serum or plasma," which are biological specimens.
- Methodology: The description outlines a biochemical assay process involving reducing agents, enzymes, and a binding protein to measure a substance in the sample. This is characteristic of an in vitro diagnostic method.
The information provided clearly indicates that this device is designed to perform a diagnostic test on biological samples in vitro.
N/A
Intended Use / Indications for Use
The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JJX
Device Description
Homocysteine Microplate HPB Assay is an EIA-like assay for the determination of tHcy (L-homocysteine) in blood. The assay employs a genetically engineered Homocysteine Binding Protein (HBP) as the capturing reagent. Plasma samples are pretreated in vials with a reducing agent, TCEP, to reduce the protein bound Hcy to free Hcy that is subsequently converted to S-adenosyl-L-homocysteine (SAH) by SAH hydrolase and quantitated by the HBP in a competition assay between free SAH from samples and tracer SAH-HRP conjugate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Diazyme Homocysteine Microtiter Plate Assay and the Axis Homocysteine EIA have similar technological characteristics and have been shown to be substantial equivalent.
The following areas were evaluated and shown to be substantially equivalent comparisons to the predicate:
- Indications for Use Methodology Test Objective Type of Test Specimen Type Product Type Reagents Performance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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
SEP - 3 2003
Image /page/0/Picture/2 description: The image shows the word "DIAZYME" in bold, black letters. To the left of the word is a four-pointed star-like symbol, also in black. The symbol is made up of four diamond shapes arranged around a central point.
032012
3550 General Atomics Ct. San Diego, CA 92121 Tel: 858-455-4754 Fax: 858-455-4750
SUMMARY
Submitter's name: Address: Phone: Fax number:
Diazyme Laboratories 3550 General Atomics Ct. 858-455-4754 858-455-4750
Name of contact person:
Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
Date the summary was prepared: June 18, 2003
| Name of the device: | Homocysteine Microtiter Plate Assay |
|---|---|
| Trade or proprietary name: | Homocysteine Microplate HPB Assay |
| Common or usual name: | Homocysteine Microtiter Plate Assay |
| Classification name: | Single (specified analyte controls (per 2 CFR section 862.1660)) |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Axis Homocysteine EIA, manufactured by Axis Biochemicals, AS. The clearance number is K980907.
Description of the device:
Homocysteine Microplate HPB Assay is an EIA-like assay for the determination of tHcy (L-homocysteine) in blood. The assay employs a genetically engineered Homocysteine Binding Protein (HBP) as the capturing reagent. Plasma samples are pretreated in vials with a reducing agent, TCEP, to reduce the protein bound Hcy to free Hcy that is subsequently converted to S-adenosyl-L-homocysteine (SAH) by SAH hydrolase and quantitated by the HBP in a competition assay between free SAH from samples and tracer SAH-HRP conjugate.
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Intended use of the device:
The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Summary of the technological characteristics of our device compared to the predicate device:
The Diazyme Homocysteine Microtiter Plate Assay and the Axis Homocysteine EIA have similar technological characteristics and have been shown to be substantial equivalent.
The following areas were evaluated and shown to be substantially equivalent comparisons to the predicate:
- Indications for Use Methodology Test Objective Type of Test Specimen Type Product Type Reagents Performance
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol consists of four abstract shapes resembling birds in flight, stacked on top of each other.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 3 2003
Diazyme Laboratories c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, CA 92606
K032012 Re:
Trade/Device Name: Homocysteine Microtiter Plate Assay Regulation Number: 21 CFR 862.1377 Regulation Name: Single (specified) analyte controls Regulatory Class: Class II Product Code: LPS: JJX Dated: June 27, 2003 Received: July 2, 2003
Dear Mr. Holland:
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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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l of of l Page_
510(k) Number (if known): K032012
Device Name: Homocysteine Microtiter Plate Assay
Indications For Use:
The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ahets Suts
Division Sign Off for Lean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032012
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)