(216 days)
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.
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA to Wallac, Inc. for their Neonatal Leucine Test Kit.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, it does not describe the specific performance, acceptance criteria, or a study that directly demonstrates the device meets these criteria.
Therefore, I cannot provide the requested information based on the given text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white.
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.
{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 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 (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 (301) 443-6597, 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
{2}------------------------------------------------
WALLAC NEONATAL LEUCINE TEST SIQ(k)
Image /page/2/Picture/1 description: The image shows the logo for EG&G, a former American science and technology company. The logo consists of a stylized three-pronged symbol to the left of the company name, "EG&G". The letters are in a bold, sans-serif font, and there is an ampersand between the two G's. A small superscript dot is located to the upper right of the second "G".
WALLAC, INC.
DRAWER 4350 AKRON, OHIO 44321-0350 PHONE: (330) 825-4525 (800) 321-9632 FAX: (330) 825-8520
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)
§ 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.