(48 days)
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Not found
No
The summary describes a quantitative measurement kit for a biochemical marker, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a diagnostic kit used for screening newborns for galactosemia, not for treating a disease or condition.
Yes
The device is used to screen newborns for galactosemia, which is a medical condition. This indicates a diagnostic purpose.
No
The device is described as a "Total Galactose kit" used for measuring Total Galactose in dried blood spot samples. This description strongly implies the use of physical components (reagents, collection materials, etc.) and not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kits are used for the "quantitative measurement of Total Galactose in neonatal dried blood spot samples." This involves testing a biological sample (blood) outside of the body (in vitro).
- Purpose: The results are used to "screen newborns for galactosemia," which is a diagnostic purpose.
- Sample Type: The device analyzes "dried blood spot samples," which are biological specimens.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatal
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1310 Galactose test system.
(a)
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.(b)
Classification. Class I.
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.
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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 (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 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
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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)