(248 days)
In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
Not Found
I am sorry, but the provided text from the FDA document (K982003) is a 510(k) clearance letter for a diagnostic device (DS30 Hcy Homocysteine Assay Kit), not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, the document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. These details would typically be found in the device's premarket submission or a separate validation study report, not in the clearance letter itself.
The document only specifies:
- Device Name: DS30 Hcy Homocysteine Assay Kit
- Intended Use: In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.
Without a detailed study report, I cannot provide the requested information.
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FEB 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Andrew Kenney Research & Development Director Drew Scientific Limited Sowerby Woods Industrial Estate Barrow-in-Furness Cumbria LA14 4QR UK ENGLAND
Re: K982003
Trade Name: DS30 Hcy Homocysteine Assay Kit Regulatory Class: II Product Code: LPS Dated: January 27, 1999 Received: February 1, 1999
Dear Dr. Kenney:
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 Butman
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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| 510(k) Number (if known): | K982003 |
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| Device Name: |
Indications For Use:
Drew Scientific Limited
Indication for use 11.0
ﺮ ﺗﻘ
In vitro quantitative measurement of total homocysteine (tHcy) concentration in
plasma for detection of hyperhomocysteinemia.
Jein Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices K987.003 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
O
.
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.