WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

K982307 · Wallac, Inc. · JNB · Feb 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K982307
• Device Name: WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
• Applicant: Wallac, Inc.
• Product Code: JNB · Clinical Chemistry
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1555
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease. It is intended for use by trained, qualified laboratory professionals.

Device Story

Wallac Neonatal Leucine Test Kit quantifies leucine and valine levels in dried blood spot specimens; used for neonatal screening of Maple Syrup Urine Disease. Device operated by trained laboratory professionals in clinical laboratory settings. Input consists of blood samples collected on filter paper; output provides quantitative concentration values for leucine and valine. Results assist clinicians in identifying neonates requiring further diagnostic evaluation for metabolic disorders.

Technological Characteristics

In vitro diagnostic test kit for quantitative analysis of amino acids in dried blood spots. Utilizes biochemical assay methods for leucine and valine detection. Intended for professional laboratory use.

Indications for Use

Indicated for the quantitative screening of leucine and valine in dried blood spot specimens from neonates to screen for Maple Syrup Urine Disease. For use by trained laboratory professionals only.

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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Public Health Service

FEB 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janice K. Brownlee Director of Regulatory Affairs Wallac, Inc. Drawer 4350 Akron, Ohio 44321-0350

K982307 Re:

Trade Name: Wallac Neonatal Leucine Test Kit Code NL-1000 Regulatory Class: II Product Code: JNB Dated: November 24, 1998 Received: November 30, 1998

Dear Ms. Brownlee:

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 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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WALLAC NEONATAL LEUCINE TEST SIQ(k)

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WALLAC, INC.

DRAWER 4350 AKRON, OHIO 44321-0350 PHONE: [phone] [phone] FAX: [phone]

## INDICATIONS FOR USE STATEMENT

510(K) Number K982307

Device name: Wallac Neonatal Leucine Test Kit

Indications For Use:

This Leucine Test is for the quantitation of leucine, and valine in blood specimens dried on filter paper. It is intended for use as a primary test for screening babies for Maple Syrup Urine Disease. It is intended for use by trained, qualified laboratory professionals.

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number _ 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pr
scription Use

or

Over-the- Counter Use

(Per 21 CFR 801.109)