(62 days)
The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria
Not Found
The perfect answer would include all the information listed in the prompt. However, based on the input provided, I cannot answer all parts fully. Here's a breakdown of what can and cannot be answered:
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document is a 510(k) clearance letter, not a study report. It does not contain acceptance criteria or performance data.
- Sample size used for the test set and the data provenance: Not mentioned in the provided text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this is a diagnostic assay, not an imaging AI.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While the device is a screening assay performed in a lab, the concept of "standalone performance" as it applies to an AI algorithm is not directly applicable or discussed in this context.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Information that CAN be extracted and inferred:
This document is primarily a 510(k) clearance letter for an in-vitro diagnostic device, specifically the "Quantase™ PHE/GAL Screening Assay." It confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This type of document typically does not include detailed study results, acceptance criteria, or ground truth methodologies for the device's validation. Those details would be found in the original 510(k) submission and supporting documentation, which is not provided here.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
FEB 16 1999
R. Stewart Campbell, Ph.D. Technical Director Quantase Ltd. 3 Riverview Business Park Friarton Road Perth PH2 8DF Scotland, UK
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K984463
Trade Name: Quantase™ PHE/GAL Screening Assay Regulatory Class: II. I Product Code: 75 JNB, 75 JIA, 75 JIX, 75 JJY Dated: December 10, 1998 Received: December 16, 1998
Dear Dr. Campbell:
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 (OS) 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.
{1}------------------------------------------------
Page 2
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 Iegally 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
{2}------------------------------------------------
| Page __ of __ |
|---|
| --------------- |
| 510(k) Number (if known): | K984463 |
|---|---|
| Device Name: | QUANTASE TM PHE/GRL |
Indications For Use:
The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme
The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received.
The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDBO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
City
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984463
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1555 Phenylalanine test system.
(a)
Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.(b)
Classification. Class II.