(117 days)
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No
The summary describes a quantitative biochemical assay for G6PD, which is a standard laboratory test and does not mention any AI/ML components or image processing.
No
The device is for in vitro diagnostic use, specifically for the quantitative determination of G6PD in blood. It is not intended for treating or diagnosing a condition in a living subject.
Yes
The 'Intended Use / Indications for Use' explicitly states "For in vitro diagnostic use only," which confirms its diagnostic purpose.
No
The intended use describes a quantitative determination of G6PD in blood, which strongly suggests a physical assay or test kit is involved, not solely software. The lack of a device description further prevents confirmation of a software-only nature.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the key indicator that the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
Product codes
JBF
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
(a)
Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.(b)
Classification. Class II (performance standards).
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 depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The text is arranged around the top half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
MAR 3 1 2003
Re: K024006 Trade/Device Name: Glucose-6-Phosphate Dehydrogenase (G6PD) Reagent Set Regulation Number: 21 CFR § 864.7360 Regulation Name: Erythrocytic glucose-6-phosphate dehydrogenase assay Regulatory Class: II Product Code: JBF Dated: February 28, 2003 Received: March 3, 2003
Dear Mr. Jamison:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if known): K024006
Device Name: G6PD, Glucose - 6 - Phosphate Dehydrogenase
Indications for use:
For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K024006 |
|---|---|
| Prescription Use | |
| Counter Use | |
| (Per 21 CFR 801.109) | OR Over the |
(Optional Format 1-2-96)