BinaxNOW G6PD Test

K161364 · Alere Scarborough, Inc. · JBF · Jun 17, 2016 · Hematology

Device Facts

• Record ID: K161364
• Device Name: BinaxNOW G6PD Test
• Applicant: Alere Scarborough, Inc.
• Product Code: JBF · Hematology
• Decision Date: Jun 17, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7360
• Device Class: Class 2

Indications for Use

The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.

Device Story

Lateral flow test strip; utilizes enzyme chromatography to detect G6PD activity in venous whole blood. Input: whole blood sample mixed with RBC lysing reagent. Principle: G6PD enzyme reduces nitro blue tetrazolium dye to blue formazan. Output: visual color change on reaction pad; red color indicates deficiency; brown/black color indicates normal activity. Used in clinical settings by healthcare professionals. Provides rapid screening to identify G6PD deficiency; facilitates clinical decision-making regarding patient treatment; requires quantitative follow-up for deficient results.

Clinical Evidence

Prospective study (2007-2008) with 246 subjects. Compared BinaxNOW® to a quantitative G6PD method (cut-off 4.2 U/gHb). Heparin samples: 98.0% deficient agreement, 97.9% normal agreement. EDTA samples: 98.0% deficient agreement, 97.4% normal agreement. Reproducibility study (3 sites, 6 operators) showed 98.4% agreement. Precision study (single operator, 10 days) showed 100% agreement for normal and deficient samples.

Technological Characteristics

Lateral flow immunoassay; qualitative detection. Modification: expanded storage temperature range (2–30°C). No changes to fundamental scientific technology or assay components.

Indications for Use

Indicated for the qualitative detection of glucose-6-phosphate dehydrogenase (G6PD) in human blood samples.

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.

Predicate Devices

• BinaxNOW® G6PD Test (K080003)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K161364

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: BinaxNOW® G6PD Test, K080003.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for expansion of the storage temperature range. In addition, modifications were made to the labeling, including package insert and outer box labeling, to reflect the changes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is the expanded storage temperature from 15–30°C to 2–30°C.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. A risk assessment of expanding the storage temperature range from 15–30°C to 2–30°C was conducted and documented per Quality System requirements. Failure Modes and Effects Analysis (FMEA) was used to assess risk. The modification made to the BinaxNOW® G6PD Test does not affect the assay procedure and this change does not impact the performance of the test or its safety and effectiveness. An update to the product labeling was required to reflect this expanded storage temperature range.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. To support the expanded storage temperature range, real-time stability data on three lots of test devices and three lots of Reagent A were collected throughout the claimed shelf life at the extremes of storage temperature, 2–8°C and 30°C. The results support BinaxNOW® G6PD Test shelf life of 24 months when stored at 2–30°C.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.