(295 days)
Not Found
No
The device description and performance studies indicate a simple lateral flow assay with visual interpretation, with no mention of AI or ML.
No
The device is a diagnostic test used to detect G6PD deficiency, not to treat or cure a condition.
Yes
The device qualitatively detects G6PD enzyme activity in blood to aid in identifying G6PD deficiency, which is a diagnostic purpose.
No
The device description clearly outlines a physical lateral flow test strip with chemical reagents, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the BinaxNOW® G6PD Test is an "in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. It also states the test is intended to "aid in the identification of people with G6PD deficiency," which is a diagnostic purpose.
- Device Description: The description details a test strip and reagents used to analyze a biological sample (whole blood) outside of the body to determine a medical condition (G6PD activity).
- Anatomical Site: The test is performed on "human venous whole blood," which is a biological specimen collected from the body.
- Performance Studies: The document describes clinical studies where the device was used to test human blood samples and the results were compared to a commercially available quantitative G6PD test. This is typical for the validation of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K933934; Trinity Biotech Glucose-6-Phosphate Dehydrogenase (G-6-PDH) Deficiency reagent set) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JBF
Device Description
The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.
To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.
Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A prospective study conducted in 2007-2008 in the U.S. Both heparinized and EDTA whole blood specimens were collected from 246 subjects and were evaluated on the BinaxNOW® test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Sample Performance – BinaxNOW® G6PD Test Method Comparison: The performance of the BinaxNOW® test was compared to a commercially available quantitative G6PD test in a prospective study conducted in 2007-2008 in the U.S. Both heparinized and EDTA whole blood specimens were collected from 246 subjects and were evaluated on the BinaxNOW® test. All of the samples that generated a value less than or equal to 2.0 U/gHb on the comparative method generated deficient results on the BinaxNOW G6PD test. The percent agreement analyses and 95% confidence intervals for the BinaxNOW® G6PD test results for detection of G6PD enzyme activity deficiency, as compared to the comparative method, on both heparinized and EDTA blood samples, is provided below. For both sample types, a comparative method cut-off value of 4.2 U/gHb was used in the analysis. For all results less than or equal to 4.2 U/qHb on the comparative method, a deficient BinaxNOW result was considered a correct result. Likewise, for all comparative method results greater than 4.2 U/gHb, a normal BinaxNOW result was considered a correct result.
Interfering Substances: The BinaxNOW® G6PD test was evaluated for possible interference from high levels of endogenous blood components. Whole blood samples were tested that contained bilirubin (conjugated and unconjugated), triglycerides, total cholesterol, lactic acid, lactate dehydrogenase, or glucose at concentrations above physiological levels. None of the endogenous blood components affected test performance. The presence of an elevated level of copper sulfate, which is known to inhibit G6PD enzyme activity, was also evaluated and did not affect test performance. Blood samples with abnormally low and high hematocrit levels (17-18% and 54-65% respectively) were evaluated, and test performance was affected as described in the Limitations section of the package insert.
Reproducibility Study - Multiple Operators: A blind study of the BinaxNOW® G6PD Test was conducted at 3 separate sites using panels of blind coded specimens, which included G6PD normal and deficient samples. Participants tested each sample multible times on 3 different days. There was 98.4% (123/125) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between operators (6 operators).
Precision Study - Single Operator: Blood samples from two individuals were drawn into both EDTA and heparin collection tubes, and all 4 samples were tested in duplicate on the BinaxNOW test on ten successive days by a single operator. The samples collected from one individual were interpreted as normal 100% of the time. The samples collected from the other individual were interpreted as deficient 100% of the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
% AGREEMENT WITH HEPARIN SAMPLES:
"Deficient result" percent agreement = 48 / 49 = 98.0% (CI = 89.3 - 99.6%)
"Normal result" percent agreement = 190 / 194 = 97.9% (Cl = 94.8 - 99.2%)
Overall percent agreement = 238 / 243* = 97.9% (CI = 95.3 - 99.1%) (* 3 invalid tests)
% AGREEMENT WITH EDTA SAMPLES:
"Deficient result" percent agreement = 49 / 50 = 98.0% (Cl = 89.5 - 99.6%)
"Normal result" percent agreement = 191 / 196 = 97.4% (Cl = 94.2 - 98.9%)
Overall percent agreement = 240 / 246 = 97.6% (CI = 94.8 - 98.9%)
Additionally, BinaxNOW® test results on the heparin samples were the same as the results on the EDTA samples for 240 of the 243 subjects, whose samples generated valid results on both sample types, yielding a percent agreement of 99%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Trinity Biotech Glucose-6-Phosphate Dehydrogenase (G-6-PDH) Deficiency reagent set. #K933934.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
ATTACHMENT 3
510(k) SUMMARY (Updated October 21, 2008)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K080003
SUBMITTER
Binax, Inc., d/b/a Inverness Medical 10 Southgate Road Scarborough, Maine 04074 (207) 730-5739 (Office) (207) 730-5717 (FAX) Establishment Registration Number: 1221359
CONTACT PERSON
Anne Jepson anne.jepson@invmed.com (email)
DATE PREPARED
December 31, 2007 (revised October 21, 2008)
TRADE NAME BinaxNOW® G6PD Test
COMMON NAME
BinaxNOW® G6PD Test, BinaxNOW® G6PD, Binax NOW® G6PD Test, Binax NOW® G6PD, NOW® G6PD Test, NOW® G6PD
CLASSIFICATION NAME
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening (per 21 CFR 864.7360)
PREDICATE DEVICE
Trinity Biotech Glucose-6-Phosphate Dehydrogenase (G-6-PDH) Deficiency reagent set. #K933934.
DEVICE DESCRIPTION
The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.
To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.
1
Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.
INTENDED 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.
TECHNOLOGICAL CHARACTERISTICS
The BinaxNOW® G6PD Test and the predicate Trinity Biotech Glucose-6-Phosphate Dehydrogenase (G-6-PDH) Deficiency reagent set utilize different technologies. The BinaxNOW® test uses lateral flow, enzyme chromatographic technology, while the Trinity Biotech G-6-PDH Deficiency reagent set is a liquid system fluorescing "spot" assay. Both tests are qualitative tests for the visual determination of G6PD deficiency in whole blood.
PERFORMANCE SUMMARY
Clinical Sample Performance – BinaxNOW® G6PD Test Method Comparison
The performance of the BinaxNOW® test was compared to a commercially available quantitative G6PD test in a prospective study conducted in 2007-2008 in the U.S. Both heparinized and EDTA whole blood specimens were collected from 246 subjects and were evaluated on the BinaxNOW® test.
All of the samples that generated a value less than or equal to 2.0 U/gHb on the comparative method generated deficient results on the BinaxNOW G6PD test.
The percent agreement analyses and 95% confidence intervals for the BinaxNOW® G6PD test results for detection of G6PD enzyme activity deficiency, as compared to the comparative method, on both heparinized and EDTA blood samples, is provided below. For both sample types, a comparative method cut-off value of 4.2 U/gHb was used in the analysis. For all results less than or equal to 4.2 U/qHb on the comparative method, a deficient BinaxNOW result was considered a correct result. Likewise, for all comparative method results greater than 4.2 U/gHb, a normal BinaxNOW result was considered a correct result.
2
% AGREEMENT WITH HEPARIN SAMPLES:
| Comparative | Method → | ||
|---|---|---|---|
| Deficient | Normal | ||
| BinaxNOW | Deficient | 48 | 4 |
| Test → | Normal | 1 | 190 |
"Deficient result" percent agreement = 48 / 49 = 98.0% (CI = 89.3 - 99.6%) "Normal result" percent agreement = 190 / 194 = 97.9% (Cl = 94.8 - 99.2%) Overall percent agreement = 238 / 243* = 97.9% (CI = 95.3 - 99.1%) (* 3 invalid tests)
% AGREEMENT WITH EDTA SAMPLES:
| Comparative | Method → | ||
|---|---|---|---|
| Deficient | Normal | ||
| BinaxNOW | Deficient | 49 | 5 |
| Test → | Normal | 1 | 191 |
"Deficient result" percent agreement = 49 / 50 = 98.0% (Cl = 89.5 - 99.6%) "Normal result" percent agreement = 191 / 196 = 97.4% (Cl = 94.2 - 98.9%) Overall percent agreement = 240 / 246 = 97.6% (CI = 94.8 - 98.9%)
Additionally, BinaxNOW® test results on the heparin samples were the same as the results on the EDTA samples for 240 of the 243 subjects, whose samples generated valid results on both sample types, yielding a percent agreement of 99%.
Interfering Substances
The BinaxNOW® G6PD test was evaluated for possible interference from high levels of endogenous blood components. Whole blood samples were tested that contained bilirubin (conjugated and unconjugated), triglycerides, total cholesterol, lactic acid, lactate dehydrogenase, or glucose at concentrations above physiological levels. None of the endogenous blood components affected test performance. The presence of an elevated level of copper sulfate, which is known to inhibit G6PD enzyme activity, was also evaluated and did not affect test performance.
Blood samples with abnormally low and high hematocrit levels (17-18% and 54-65% respectively) were evaluated, and test performance was affected as described in the Limitations section of the package insert.
Reproducibility Study - Multiple Operators
A blind study of the BinaxNOW® G6PD Test was conducted at 3 separate sites using panels of blind coded specimens, which included G6PD normal and deficient samples. Participants tested each sample multible times on 3 different days. There was 98.4% (123/125) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between operators (6 operators).
Precision Study - Single Operator
3
Blood samples from two individuals were drawn into both EDTA and heparin collection tubes, and all 4 samples were tested in duplicate on the BinaxNOW test on ten successive days by a single operator. The samples collected from one individual were interpreted as normal 100% of the time. The samples collected from the other individual were interpreted as deficient 100% of the time.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Binax, Inc. Ms. Anne Jepson 10 Southgate Road Scarborough, Maine 04074
OCT 23 2008
Re: K080003
Trade/Device Name: BinaxNOW® G6PD Test Regulation Number: 21 CFR 864.7360 Regulation Name: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening Regulatory Class: Class II Product Code: JBF Dated: September 19, 2008 Received: Oct 15, 2008
Dear Ms. Jepson:
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
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Page 2 - Ms. Jepson
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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Maria mchen
Maria Chan, Ph.D Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known)
510(k) Number (if known): K080003
Device Name: BinaxNOW® G6PD Test
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.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | √ |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Division Evaluation (ODE)
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K080003
Revision 12/28/07