K Number
K984463
Device Name
QUANTASE PHE/GAL SCREENING ASSAY
Manufacturer
Date Cleared
1999-02-16

(62 days)

Product Code
Regulation Number
862.1555
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
Device Description
Not Found
More Information

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No
The summary describes an enzymatic colorimetric assay and does not mention any AI or ML components.

No
This device is an enzymatic colorimetric test used for screening L-phenylalanine and total D(+)galactose in dried blood spots for newborn screening, not for treatment.

No
The text explicitly states: "The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose. The test results are not diagnostic per se of phenylketonuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received." This indicates it's a screening tool, not a diagnostic one.

No

The description clearly states the device is an "enzymatic colorimetric end-point method" for analyzing dried blood spot specimens. This indicates a chemical assay and likely associated hardware (e.g., spectrophotometer, plate reader), not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • "In Vitro": The test is performed on a biological specimen (dried blood spot) taken from the human body, but the test itself is conducted outside of the body.
  • "Diagnostic": While the test results are not diagnostic per se, the intended use clearly states it is a "screening method for measuring" specific analytes (L-phenylalanine and total D(+)galactose) in order to identify newborns who require further investigation for phenylketonuria or galactosemia. This screening function is a key aspect of in vitro diagnostics, as it provides information used in the diagnostic process.

The description explicitly states it's a "screening method" for measuring substances in a biological sample, which aligns perfectly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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

Product codes

75 JNB, 75 JIA, 75 JIX, 75 JJY

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

Not Found

Indicated Patient Age Range

newborn human infants

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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)