(70 days)
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No
The summary describes a quantitative in vitro diagnostic test for homocysteine, which is a standard laboratory assay and does not mention any AI or ML components.
No.
The device is for in vitro diagnostic (IVD) use, specifically for quantitative determination of total homocysteine, to assist in diagnosis and treatment, which is a diagnostic purpose, not directly therapeutic.
Yes
The device is described as assisting "in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria," indicating its role in identifying or confirming a medical condition.
No
The device is described as an in vitro diagnostic test kit, including a test, calibrators, and controls, which are physical components used in a laboratory setting. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma..." The phrase "in vitro determination" is a key indicator of an IVD.
- "This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This indicates a medical purpose related to diagnosis and treatment, which is characteristic of IVDs.
- "The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma." Calibrators used with an assay for measuring substances in human samples for medical purposes are also considered IVDs.
- "The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc." Quality controls used in laboratory testing of human samples for medical purposes are also considered IVDs.
All of these descriptions align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.
The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.
Note: The parameters and labeling provided are for use on the Polymedco Poly-Chem and the Hitachi chemistry analyzer systems.
Product codes
LPS; JIT; 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): 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.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
ood and Drug Administratio 2098 Gaither Road Rockville MD 20850
FEB - 4 2004
Ms. Helen Landicho Director Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567
Re: K033706
Trade/Device Name: Polymedco Homocysteine Test Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS: JIT; JJX Dated: November 25, 2003 Received: November 26, 2003
Dear Ms. Landicho:
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.
Jain M. Cooper, MS, DVM.
Yean 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 (if known): 033706
Device Name: Polymedco Homocysteine Test
Indications For Use:
The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.
The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.
Note: The parameters and labeling provided are for use on the Polymedco Poly-Chem and the Hitachi chemistry analyzer systems.
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)
Carol C. Benson / Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) _______________________________________________________________________________________________________________________________________________________________________