(65 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Diazyme Homocysteine Microtiter Plate Assay, comparing it to an existing predicate device (Axis Homocysteine EIA). However, it does not explicitly state acceptance criteria or provide a detailed study report that proves the device meets specific acceptance criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a previously cleared device (Axis Homocysteine EIA, K980907), rather than presenting a standalone performance study with defined acceptance criteria.
Therefore, many of the requested elements (like sample size for test set, number of experts, adjudication method, MRMC study, ground truth for test set and training set, and training set size) are not available in the provided text.
Based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
Since explicit acceptance criteria are not provided, this table will reflect the general comparison points for substantial equivalence. The "performance" mentioned in the document refers to the overall comparability to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Indications for Use | Substantially equivalent to predicate |
| Methodology | Substantially equivalent to predicate |
| Test Objective | Substantially equivalent to predicate |
| Type of Test Specimen | Substantially equivalent to predicate |
| Product Type | Substantially equivalent to predicate |
| Reagents | Substantially equivalent to predicate |
| Performance | Substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in the provided text. The document states "The following areas were evaluated and shown to be substantially equivalent comparisons to the predicate," implying a performance comparison was done, but specific details about the study design, sample size, or data provenance are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/available. This type of information is typically related to diagnostic accuracy studies where expert consensus or interpretations are used to establish a "ground truth" for a classification task. For a quantitative assay like this, the ground truth would likely be established by a reference method or known concentrations, not expert consensus in the same way. The document does not describe the method for establishing "ground truth" for any performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/available. Adjudication methods are relevant when multiple readers/experts are interpreting results that require consensus. This is not described for the performance comparison of this quantitative assay.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document describes a quantitative assay for Homocysteine, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, implicitly. The "Performance" evaluation (mentioned as one of the areas shown to be substantially equivalent) would typically involve testing the device (the assay) directly against the predicate device to demonstrate similar analytical characteristics. This essentially represents the standalone performance of the assay. However, no specific details of this standalone performance study are provided (e.g., number of samples, statistical methods, specific metrics).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not explicitly stated, but likely a reference method or known concentrations. For a quantitative assay measuring a biomarker like homocysteine, the "ground truth" for evaluating performance (precision, accuracy, linearity, correlation) would typically involve:
- Reference methods: Comparing results to a gold standard method.
- Known concentrations: Testing samples with precisely determined homocysteine levels.
- Spiked samples: Adding known amounts of homocysteine to samples.
- Patient samples compared to a predicate device: As this document emphasizes substantial equivalence to the Axis Homocysteine EIA, the predicate device's results would serve as a comparative "truth" or benchmark for the performance evaluation.
8. The sample size for the training set:
Not applicable/available. This document describes a chemical assay, not an AI/machine learning model that requires a training set. If an AI component were involved, this information would be crucial, but it is not relevant to this type of device.
9. How the ground truth for the training set was established:
Not applicable/available. As mentioned above, this device is not an AI/machine learning model needing a training set.
{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.
{1}------------------------------------------------
Page 11
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).
{3}------------------------------------------------
Page 2 -
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
{4}------------------------------------------------
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)
§ 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.