ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

K991498 · Neometrics, Inc. · JIA · Jun 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991498
• Device Name: ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
• Applicant: Neometrics, Inc.
• Product Code: JIA · Clinical Chemistry
• Decision Date: Jun 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1310
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

Device Story

Accuwell™ Total Galactose kit is an in vitro diagnostic test for quantitative measurement of total galactose in neonatal dried blood spot samples. Samples are collected on S&S grade 903 filter paper. The device is used in clinical laboratory settings to screen newborns for galactosemia. Healthcare providers use the quantitative results to identify infants requiring further diagnostic evaluation for galactosemia, facilitating early clinical intervention.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic kit for quantitative measurement of total galactose in dried blood spots. Utilizes S&S grade 903 filter paper for sample collection.

Indications for Use

Indicated for the quantitative measurement of Total Galactose in neonatal dried blood spot samples collected on S&S grade 903 filter paper for the purpose of screening newborns for galactosemia.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

Public Health Service

JUN 16 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David Schwartz President Neometrics Inc. 104 Bellrose Avenue E. Northport, New York 11731

Re: K991498 Trade Name: Accuwell™ Total Galactose Regulatory Class: I Reserved Product Code: JIA Dated: April 27, 1999 Received: April 29, 1999

Dear Mr. Schwartz:

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 [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 Sutman

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 I of |

510(k) Number (if known): ├ 9 9 14 9 8

Device Name: _________________________________________________________________________________________________________________________________________________________________

and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states

Indications For Use:

ﺮ ,

Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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)