G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

K024006 · Pointe Scientific, Inc., · JBF · Mar 31, 2003 · Hematology

Device Facts

• Record ID: K024006
• Device Name: G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
• Applicant: Pointe Scientific, Inc.,
• Product Code: JBF · Hematology
• Decision Date: Mar 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7360
• Device Class: Class 2

Indications for Use

For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.

Device Story

Reagent set for quantitative determination of G6PD in blood; utilizes spectrophotometric analysis at 340 nm. Used in clinical laboratory settings by trained personnel. Measures enzyme activity to assist in diagnosis of G6PD deficiency. Provides quantitative results to healthcare providers for clinical decision-making regarding hemolytic anemia or drug-induced hemolysis risks.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the reagent set.

Technological Characteristics

In vitro diagnostic reagent set; spectrophotometric measurement at 340 nm; quantitative enzymatic assay.

Indications for Use

Indicated for the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood samples for in vitro diagnostic use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K024006 |
|----------------------|-------------------------------------------------------|
| Prescription Use | <div> <img alt="Checkbox" src="checkbox.png"/> </div> |
| Counter Use | |
| (Per 21 CFR 801.109) | OR Over the |

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