QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

K990654 · Quantase , Ltd. · JIA · Jun 21, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990654
• Device Name: QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
• Applicant: Quantase , Ltd.
• Product Code: JIA · Clinical Chemistry
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1310
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + 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 measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, 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 total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

Device Story

Quantase Total Galactose Screening Assay is an in vitro diagnostic kit for newborn screening. Input: dried blood spot specimens from newborns. Principle: enzymatic colorimetric end-point method to quantify total D(+)galactose and galactose-1-phosphate. Output: colorimetric measurement indicating total galactose concentration. Used in clinical laboratory settings by trained personnel. Elevated results serve as a presumptive positive, necessitating further diagnostic follow-up; results are not diagnostic for galactosaemia. Benefits: facilitates early identification of infants requiring further investigation for galactosemia.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Enzymatic colorimetric end-point assay. Designed for use with dried blood spot specimens. In vitro diagnostic kit format.

Indications for Use

Indicated for newborn human infants as a screening tool for total D(+)galactose (D(+)galactose + galactose-1-phosphate) levels in dried blood spot specimens. Not for monitoring galactosaemic patients or detecting ante-natal galactosaemia.

Regulatory Classification

Identification

A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

Submission Summary (Full Text)

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JUN 21 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

R. Stewart Campbell Ph.D. Technical Director Quantase Ltd. 3 Riverview Business Park Friarton Road Perth, Scotland. United Kingdom

Re: K990654

> Trade Name: Quantase™ Total Galactose Screening Assay 500 Test Kit Regulatory Class: I Reserved Product Code: JIA Dated: April 29, 1999 Received: April 29, 1999

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 (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 [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 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 [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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K 990654
Device Name: Total Galactose Screening Assay
500 Test Kit
Indications For Use:

The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + 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 measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, 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 total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ------

(Optional Format 1-2-96)