QUANTASE PHE/GAL SCREENING ASSAY

K984463 · Quantase , Ltd. · JNB · Feb 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984463
• Device Name: QUANTASE PHE/GAL SCREENING ASSAY
• Applicant: Quantase , Ltd.
• Product Code: JNB · Clinical Chemistry
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1555
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Quantase Phe/Gal Screening Assay is an enzymatic colorimetric end-point method for the determination of L-phenylalanine and total D(+)galactose (including galactose-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 concentrations. The 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. The kit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total D(+)galactose in phenylketonuric and galactosemic patients respectively, nor to detect ante-natal phenylketonuria and galactosemia or maternal phenylketonuria.

Device Story

Quantase PHE/GAL Screening Assay is an in vitro diagnostic kit for newborn screening; utilizes enzymatic colorimetric end-point methodology to measure L-phenylalanine and total D(+)galactose in dried blood spot specimens. Performed in clinical laboratory settings by trained laboratory personnel. Input consists of dried blood spots; output is a colorimetric signal indicating analyte concentration. Results serve as a presumptive screen; positive results trigger follow-up diagnostic testing. Benefits include early identification of newborns at risk for phenylketonuria or galactosemia, facilitating timely clinical intervention.

Technological Characteristics

Enzymatic colorimetric end-point assay. Designed for analysis of dried blood spot specimens. In vitro diagnostic reagent kit.

Indications for Use

Indicated for newborn human infants as a screening method for L-phenylalanine and total D(+)galactose (including galactose-1-phosphate) in dried blood spot specimens. Not for diagnostic use, monitoring of known patients, or ante-natal/maternal screening.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 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.

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

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| Page __ of __ |
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| 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

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## 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)