(95 days)
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No
The device description focuses on chemical and chromatographic methods for quantitative analysis, and the performance study compares it to an enzyme immunoassay. There is no mention of AI or ML in the provided text.
No
This device is an in vitro diagnostic (IVD) test for quantitative determination of total Homocysteine, which assists in diagnosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that "The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria." This explicitly indicates a diagnostic purpose.
No
The device description clearly outlines a chemical assay process involving precolumn derivatization, chromatography, and fluorescence detection, which are hardware-based laboratory techniques. While it mentions a "Bio Rad Clinical Data Management System" (K960392) for quantitative analysis, the core of the device is a chemical test kit, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is a clear indicator that the device is intended for use outside of the body to diagnose or treat conditions.
- Purpose: The device is intended for the "quantitative determination of total Homocysteine in human plasma or serum." This analysis of biological samples is a core function of IVDs.
- Clinical Application: The device "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria." This directly relates to providing information for clinical decision-making, which is a key characteristic of IVDs.
N/A
Intended Use / Indications for Use
The Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or serum.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria.
For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JIT
Device Description
The Bio-Rad Homocysteine by HPLC test is based on precolumn derivatization and a 5 minute chromatography. The precolumn derivatization includes a release of the plasma/serum bound fraction of Homocysteine by a chemical reduction and subsequent fluorescent labeling with a thiolspecific dye. Reduction and derivatization require only 5 minute incubation. Separation of Homocysteine, Internal Standard and other biological thiols (Glutathione, Cysteine, Cysteinglycine) takes place on a selected Reversed Phase cartridge followed by fluorescence detection (lex = 385 nm, lem = 515 nm). Quantitative analysis is performed using the Bio Rad Clinical Data Management System (K960392).
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
Not Found
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)
A correlation study to determine accuracy of the Bio-Rad Laboratories Homocysteine by HPLC assay was done against the AXIS® Homocysteine Enzyme Immunoassay method. The coefficient of correlation was 0.9472, the slope was 1.023, and the Y-Intercept was -0.542.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.5 µMol/L
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.
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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.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in a rounded rectangle shape with the words "BIO-RAD" in bold, white letters against a black background. The letters are slightly stylized, giving the logo a modern and recognizable appearance.
Bio-Rad Laboratories Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547 Telephone: 510 724 - 7000 Fax: 510 741-5824
DEC 2 1 1999
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:993107___
| Submitter: | Bio-Rad Laboratories
Diagnostics Group
4000 Alfred Nobel Drive
Hercules, California 94547
Phone: (510) 741-6263
FAX: (510) 741-6471 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia M. Klimley
Regulatory Affairs Consultant |
| Date of Summary Preparation: | September 16, 1999 and November 29, 1999 |
| Device Name: | Bio-Rad Homocysteine by HPLC |
| Classification Name: | Urinary homocysteine (non-quantitative) test system |
| Predicate Device: | Axis® Homocysteine Enzyme Immunoassay
Axis® Biochemicals, ASA
Oslo, Norway
K980907 |
| Statement of Intended Use: | The Bio-Rad Homocysteine by HPLC test is intended
for the quantitative determination of total
Homocysteine in human plasma or serum.
For in vitro diagnostic use only. |
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Description of Device
The Bio-Rad Homocysteine by HPLC test is based on precolumn derivatization and a 5 minute chromatography. The precolumn derivatization includes a release of the plasma/serum bound fraction of Homocysteine by a chemical reduction and subsequent fluorescent labeling with a thiolspecific dye. Reduction and derivatization require only 5 minute incubation. Separation of Homocysteine, Internal Standard and other biological thiols (Glutathione, Cysteine, Cysteinglycine) takes place on a selected Reversed Phase cartridge followed by fluorescence detection (lex = 385 nm, lem = 515 nm). Quantitative analysis is performed using the Bio Rad Clinical Data Management System (K960392).
Testing To Establish Substantial Equivalence
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness, the Bio-Rad Homocysteine by HPLC is compared to the AXIS® Homocysteine Enzyme Immunoassay (K980907). A review of the intended use of each system shows them to be the same, in that, both methods are intended for the quantitative measurement of homocysteine.
| Parameter | Bio-Rad Homocysteine by
HPLC | AXIS®Homocysteine
Enzyme Immunoassay | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Analytes Measured/Reported | Homocysteine | Homocysteine | | | | | | | | | | | | | | | | | | | | | | | | |
| Basic Principle | Chromatography | Immunoassay | | | | | | | | | | | | | | | | | | | | | | | | |
| Derivatization | Pre-column | Enzymatic conversion to
SAH | | | | | | | | | | | | | | | | | | | | | | | | |
| Separation Mechanism | Reverse Phase | Monoclonal Antibody | | | | | | | | | | | | | | | | | | | | | | | | |
| Detection Mechanism | Fluorescence | Spectrophotometric | | | | | | | | | | | | | | | | | | | | | | | | |
| Measurement Type | Quantitative | Quantitative | | | | | | | | | | | | | | | | | | | | | | | | |
| Sample Type | Serum or Plasma | Serum or Plasma | | | | | | | | | | | | | | | | | | | | | | | | |
| Calibrators | Single ( 15 - 20 µMol/L) | 2, 4, 8, 15, 30, & 50 µMol/L | | | | | | | | | | | | | | | | | | | | | | | | |
| Reportable Range | 0.5 - 100 µMol/L | 2 - 50 µMol/L | | | | | | | | | | | | | | | | | | | | | | | | |
| Precision | µMol/L: Within Run Total Low 8.25 3.77% 4.40% Mid 19.53 1.87% 2.60% High 39.96 1.16% 2.74% | | | | | | | | | | | | | µMol/L: Within Run Total Low 6.1 7.3% 9.3% Mid 10.3 6.8% 8.1% High 21.4 5.2% 7.1% | | | | | | | | | | | | |
| Sensitivity | 0.5 µMol/L | 0.5 µMol/L | | | | | | | | | | | | | | | | | | | | | | | | |
| Expected Values (95%
Confidence Limit) | 5.7 - 15.1 µMol/L | 5 - 15 µMol/L | | | | | | | | | | | | | | | | | | | | | | | | |
Technical Characteristics Compared to Predicate
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A correlation study to determine accuracy of the Bio-Rad Laboratories Homocysteine by HPLC assay was done against the AXIS® Homocysteine Enzyme Immunoassay method. The coefficient of correlation was 0.9472, the slope was 1.023, and the Y-Intercept was -0.542.
When considering an excellent correlation between the AXIS® Homocysteine Enzyme Immunoassay and the Bio-Rad Laboratories Homocysteine by HPLC method, it can be concluded that the Bio-Rad Laboratories Homocysteine by HPLC assay is substantially equivalent to the AXIS® Homocysteine Enzyme Immunoassay method, which has been 510K cleared. Based on the establishment of substantial equivalence, the safety and effectiveness of the Bio-Rad Laboratories Homocysteine by HPLC assay is confirmed.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left. The eagle is composed of three thick, curved lines that suggest the shape of the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 1999
Ms. Patricia M. Klimley Regulatory Affairs Consultant Bio-Rad Laboratories, Inc. Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547
K993107 Re:
Trade Name: Homocysteine by HPLC Regulatory Class: II Product Code: LPS. JIT Dated: November 29 Received: November 30
Dear Ms. Klimley
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number:
Device Name:
Indications for Use:
Bio-Rad Homocysteine by HPLC
The Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or serum.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria.
For in vitro diagnostic use only.
Jean Corce
(Division Sign-Off)
Division of Clir.ice La ratory Device 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptive Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use _
Bio-Rad Homocysteine by HPLC 3