(876 days)
Not Found
No
The description focuses on electrowetting-based digital microfluidics and standard analytical performance metrics, with no mention of AI or ML.
No
The device is intended for the measurement of G6PD for identification of G6PD deficient samples. It is a diagnostic device used for identifying G6PD deficient samples, not a therapeutic device meant to treat or cure a condition.
Yes
The device is intended for semi-quantitative measurement of G6PD for the "identification of G6PD deficient samples," which is a diagnostic purpose.
No
The device description explicitly states that the FINDER G6PD test system consists of both a FINDER G6PD Test Cartridge and a FINDER Instrument, which contains hardware components like electrowetting control, thermal control, detection capability, and a touch-screen user interface, in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens... for the identification of G6PD deficient samples." This describes a test performed in vitro (outside the body) on a biological specimen (whole blood) to provide information about a medical condition (G6PD deficiency).
- Device Description: The description details a system that analyzes a blood specimen using reagents and an instrument to produce a measurement. This is characteristic of an IVD.
- Performance Studies: The document describes clinical performance studies comparing the device to a "predicate method" and analyzing metrics like agreement and sensitivity, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K024006) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the 510(k) submission process for IVDs.
N/A
Intended Use / Indications for Use
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
Product codes (comma separated list FDA assigned to the subject device)
JBF
Device Description
The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction.
The FINDER G6PD test system consists of the following main components.
-
FINDER G6PD Test Cartridge – The FINDER Cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps required to perform the G6PD test. The cartridge is sinqle-use and contains all the reagents necessary to perform the test.
-
FINDER Instrument – The FINDER Instrument contains all the hardware and software required to operate the FINDER Cartridge. The instrument provides electrowetting control, thermal control and detection capability, required to perform the G6PD test. The instrument also provides a touch-screen user interface and software necessary to perform the test and report results.
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
point of care or clinical laboratory settings.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
7.1. Nonclinical Performance
7.1.1. Precision
Two precision studies (internal and external) were performed to evaluate the repeatability and reproducibility precision of the FINDER G6PD test. Precision was evaluated in accordance with the CLSI EP05-A3 guideline.
The single site precision study was conducted at one site over a period of 21 non-consecutive days with 2 sessions per day and 2 runs per session. A session was defined as a batch of multiple runs where each session was separated by at least two hours. A run was defined as a single instance of a sample being tested. Results were determined using three levels of hemolysate control samples (low = 1.4 U/gHb, medium = 7.0 U/gHb, high = 17.4 U/gHb) resulting in 84 replicates per level. The study was conducted on 3 instruments using 3 cartridge lots.
The reproducibility study was conducted at 3 sites using fresh whole blood samples that were prepared each of 5 days by appropriate dilution to obtain 3 target G6PD levels (low = 8.0 U/g Hb) per day. Each day aliquots at the three sample levels were delivered to each testing site, where they were subdivided into 8 samples that were evaluated on 2 instruments by 2 operators, with 2 replications each. A total of 15 samples (3 G6PD levels, prepared on each of 5 days) were evaluated, and each sample was measured by the FINDER Instrument 24 times (across 3 sites, 2 instruments, 2 operators per site, 2 replicates), resulting in a total of 360 measurements for analysis.
7.1.2. Linearity
Linearity was evaluated in accordance with CLSI EP06-A. Two separate studies were conducted to evaluate linearity. The first study was a full range linearity study that used contrived samples of recombinant G6PD enzyme spiked into whole blood to achieve activity levels that cover the intended linear range of the test. Nine samples were generated with increasing levels of G6PD activity from 2.0 to 19.7 U/gHb.
The second study was a native linearity study that used whole blood from a normal and G6PDdeficient donor. The native linearity study was performed to ensure that linearity demonstrated in the full range linearity study with contrived samples is not an artifact associated with usage of recombinant G6PD. Nine samples were generated with increasing levels of G6PD activity from 0.8 to 13.9 U/gHb.
Key results: The linear range for the FINDER G6PD test is given by the full range of both linearity studies. The FINDER G6PD test was demonstrated to be linear from 0.8 to 19.7 U/g Hb.
7.1.3. Interference
Interference was evaluated in accordance with CLSI EP07 3rd edition quidelines. Whole blood test samples were spiked with possible interfering substances at concentrations equal to or greater than the quidelines. Each whole blood sample was tested at two G6PD enzymatic activity levels: normal G6PD activity (>7 U/qHb) and near the medical decision level (MDL near 2 – 4 U/gHb). Spiked samples (test pools) were compared to control pool without the interfering substances.
Key results: Hematocrit values greater than 40% did not interfere with the G6PD test result. A bias of -15.3% was observed for a normal sample at 29% hematocrit (8.9 g/dL hemoqlobin on FINDER) as compared to the control pool of 50% hematocrit (15.3 g/dL hemoglobin on FINDER). A bias of -11.1% was observed for a sample near the medical decision level at 30% hematocrit (11.3 g/dL hemoqlobin on FINDER). as compared to the control pool of 50% hematocrit (15.3 g/dL hemoglobin on FINDER).
The following endogenous substances were found to be non-interfering at the maximum tested concentrations: Bilirubin (50 mg/dL), Hemoglobin (5 g/L), Intralipid (1000 mg/dL), Glucose (55 mM), Galactose (1 mM), Copper (0.150 mg/dL), Lactate (90 mg/dL), Lactate dehydrogenase (6000 U/L).
The following common drugs were found to be non-interfering at the maximum tested concentrations: Ampicillin (0.16 mM), Ibuprofen (2.5 mM).
7.1.4. Sensitivity
The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) for the FINDER G6PD test were evaluated in accordance with CLSI EP17-A2.
The LoB was evaluated using whole blood altered to a blank G6PD activity; the LoD was evaluated using whole blood at low G6PD activity; the LoQ was evaluated using four whole blood samples with increasing levels of G6PD activity prepared by spiking a blank pool with increasing concentrations of a normal pool.
The studies were conducted using 3 lots of FINDER G6PD Cartridges on 6 FINDER Instruments.
Key results: Limit of Blank (LoB) = 0.2 U/g Hb, Limit of Detection (LoD) = 0.4 U/g Hb, Limit of Quantitation (LoQ) = 1.1 U/g Hb.
Clinical Performance 8.
8.1. Method Comparison with Predicate Method
A clinical method comparison study was performed to demonstrate and compare the clinical performance of the FINDER Instrument and the FINDER G6PD Cartridge test to a comparator method using venous whole blood sample collected in lithium heparin tubes. The study design for this method comparison study was based on CLSI EP09-c – Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
Sample size: Lithium heparinized whole blood samples from 200 subjects were analyzed on the FINDER Instrument across 6 collection sites.
Whole blood samples were shipped to a central laboratory under refrigerated conditions to analyze using the comparator method.
The samples tested were collected from 6 sites including one biorepository. Subjects included 89 males and 92 females with ages ranging from 20 to 72 years. 19 contrived samples were included in the study.
Key results: G6PD activity results were compared using a Deming Regression linear fit yielding an estimated slope of 0.92, an intercept of 0.28, and a correlation coefficient of 0.9.
The bias and percentage bias at the medical decision levels are shown in the table below:
MDLs: 3.1 U/gHb (30% of AMM), Bias: 0.0 U/gHb (-0.1, 0.2), %Bias: 1.4% (-2.5%, 5.4%)
MDLs: 8.4 U/gHb (80% of AMM), Bias: -0.4 U/gHb (-0.5, 0.2), %Bias: -4.3% (-6.5%, -2.0%)
A concordance analysis was performed where the first 36 normal male samples were used to calculate the adjusted male median. The remaining 167 samples were used in the data analysis.
The adjusted male median for the FINDER G6PD Test was 10.45 U/gHb. The adjusted male median for the Pointe Scientific G6PD test run on Cobas Mira was 10.88 U/gHb.
Agreement between the FINDER G6PD Test and the Pointe Scientific Glucose-6-Phosphate Dehydrogenase Reagent Set on Cobas Mira using different cutoffs (70% FINDER G6PD Test: 98.1% Agreement (Wilson Score 95% CI: 93.4%, 99.5%)
Overall Agreement: 92.8% (Wilson Score 95% CI: 87.9%, 95.8%)
Agreement between the FINDER G6PD Test and the Pointe Scientific Glucose-6-Phosphate Dehydrogenase Reagent Set on Cobas Mira using different cutoffs (80% FINDER G6PD Test: 93.7% Agreement (Wilson Score 95% CI: 86.9%, 97.1%)
Overall Agreement: 88.6% (Wilson Score 95% CI: 82.9%, 92.6%)
Agreement between the FINDER G6PD Test and the Pointe Scientific Glucose-6-Phosphate Dehydrogenase Reagent Set on Cobas Mira using different cutoffs (
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2022
Baebies, Inc. Candice Prowse Regulatory Affairs Specialist 615 Davis Drive Suite 800 Morrisville, North Carolina 27560
Re: K201049
Trade/Device Name: FINDER G6PD Test Regulation Number: 21 CFR 864.7360 Regulation Name: Erythrocytic Glucose-6-Phosphate Dehydrogenase Assay Regulatory Class: Class II Product Code: JBF Dated: September 14, 2022 Received: June 17, 2022
Dear Candice Prowse:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201049
Device Name FINDER G6PD
Indications for Use (Describe)
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[In accordance with 21 CFR 807.92]
Baebies, Inc.
FINDER® G6PD Test
1. Submitter / 510(k) Holder
Baebies Inc., 25 Alexandria Way, Durham, NC 27703, USA Main phone number: (919) 891-0432 Main fax number: (919) 328-8402
Contact Person: Candice Prowse, Director of Regulatory Affairs and Clinical Affairs
Date Prepared: September 12, 2022
2. Device
| Proprietary Name: | FINDER G6PD Test |
|---|---|
| 510(k) Number | K201049 |
| Classification Name: | Glucose-6-Phosphate Dehydrogenase |
| (Erythrocytic), Quantitative | |
| Classification Panel: | Hematology |
| Classification: | Class II |
| Classification Regulation: | 21 CFR 864.7360 |
| Product Code: | JBF |
3. Predicate Device
| Class | Manufacturer | 510(k)
Number | Device Name/Description |
|-------|-------------------------|------------------|------------------------------------------------------------|
| II | Pointe Scientific, Inc. | K024006 | Glucose-6-Phosphate
Dehydrogenase (G6PD) Reagent
Set |
4
4. Device Description
The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction.
The FINDER G6PD test system consists of the following main components.
-
FINDER G6PD Test Cartridge – The FINDER Cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps required to perform the G6PD test. The cartridge is sinqle-use and contains all the reagents necessary to perform the test.
-
FINDER Instrument – The FINDER Instrument contains all the hardware and software required to operate the FINDER Cartridge. The instrument provides electrowetting control, thermal control and detection capability, required to perform the G6PD test. The instrument also provides a touch-screen user interface and software necessary to perform the test and report results.
4.1. Accessories
The following accessories have not received prior 510(k) clearance.
The FINDER System includes a 50µL fixed-volume micropipette used to transfer specimens from the specimen collection device to the FINDER Cartridge for testing.
The FINDER system includes an optional thermal printer that is connected to the instrument via USB.
4.2. Test Principle
G6PD activity is measured from a whole blood sample input. Red blood cells are lysed osmotically in the cartridge by combining whole blood with water. The lysed blood cells are then incubated with ß-nicotinamide adenine dinucleotide phosphate (NADP) and glucose-6phosphate (G6P), resulting in the production of NADPH. Kinetic fluorescence measurements are used to quantify the rate of NADPH production, which is proportional to G6PD enzymatic activity. The reaction occurs in the presence of maleimide, which is used to improve the specificity of the test by inhibiting the production of NADPH from 6-phosphogluconate dehydrogenase. Hemoglobin present in the lysed sample is measured by absorbance and used to normalize G6PD enzymatic activity, resulting in a final reported unit of U/gHb.
$$G\text{"}6P + NADP^{+} \xrightarrow{G\text{"}6PD} 6-PG + NADPH + H^{+} $$
The FINDER G6PD Test reports the hemoglobin normalized G6PD activity in U/gHb and as a % of the site-specific Adjusted Male Median (AMM). The site-specific AMM is calculated using a minimum of 36 normal male samples and can be set by the user.
Baebies, Inc.
FINDER G6PD Test
5
5. Indications for Use
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples.
The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
The Indications for Use statement of the predicate is substantially the same as the candidate device. Any differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate.
6. Comparison of Technological Characteristics with Predicate
The FINDER G6PD test is intended for use on the FINDER Instrument. The similarities and differences between the FINDER G6PD Test and its predicate are presented in the following Table 1.
| Characteristic | Predicate
Pointe Scientific Glucose-6-
Phosphate Dehydrogenase
(G6PD) Reagent Set K024006) | FINDER G6PD Test |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 864.7360 | Same |
| Regulation Name | Erythrocytic glucose-6-phosphate
dehydrogenase assay | Same |
| Procode | JBF | Same |
| Intended Use | For the quantitative determination
of glucose-6-phosphate
dehydrogenase (G6PD) in blood
at 340 nm. For in vitro diagnostic
use only. | The FINDER G6PD test is
intended for semi-quantitative
measurement of glucose-6-
phosphate dehydrogenase in
venous whole blood specimens
collected in lithium heparin tubes,
for the identification of G6PD
deficient samples.
The FINDER G6PD test is
intended to be used with the
FINDER Instrument in point of care
or clinical laboratory settings |
| Characteristic | Predicate
Pointe Scientific Glucose-6-
Phosphate Dehydrogenase
(G6PD) Reagent Set K024006) | FINDER G6PD Test |
| Class | II | Same |
| Device Panel | Hematology | Same |
| Analyzer | Cobas Mira | FINDER Instrument |
| Assay Manufacturer | Pointe Scientific | Baebies, Inc. |
| Analytes | G6PD | Same |
| Linear Range | 2.78 to 20.69 U/g Hb | 0.8 to 19.7 U/g Hb |
| Limit of Blank | Not specified | 0.2 U/g Hb |
| Sensitivity
(Limit of Detection) | 0.4 U/g Hb | 0.4 U/g Hb |
| Limit of
Quantitation | Not specified | 1.1 U/g Hb |
| Specimen | Whole blood | Same |
| Method | NADPH kinetic
spectrophotometric method | NADPH kinetic fluorometric
method |
| Component
Reagent matrices | G6P, Buffer, NADP and
Maleimide | G6P, Buffer, NADP and Maleimide |
| Reagent Format | Dry and liquid, ready to use
reagents; manual reconstitution | Dry test-specific reagents and
liquid diluent and filler fluid;
reconstitution performed by
instrument |
| Detection of
analyte, Measurand | Spectrophotometric, quantitative
at 340nm | Fluorimetric, semi-quantitative
370nm Excitation/460nm Emission |
| Characteristic | Predicate
Pointe Scientific Glucose-6-
Phosphate Dehydrogenase
(G6PD) Reagent Set K024006) | FINDER G6PD Test |
| | | The FINDER G6PD Test reports
the hemoglobin normalized G6PD
activity in U/gHb and as a % of the
site-specific Adjusted Male Median
(AMM). |
| Hemoglobin | Reaction with potassium cyanide | Absorbance at 524nm |
| Controls | Hemolysate | Same |
| Calibration
Traceability | Absorptivity of NADPH | NADPH extinction coefficient of
$6.3mM^{-1}cm^{-1}$ |
Table 1 - FINDER G6PD versus Pointe Scientific G6PD Reagent Set
6
baebies
7
7. Performance Testing Summary
7.1. Nonclinical Performance
7.1.1. Precision
Two precision studies (internal and external) were performed to evaluate the repeatability and reproducibility precision of the FINDER G6PD test. Precision was evaluated in accordance with the CLSI EP05-A3 guideline.
The single site precision study was conducted at one site over a period of 21 non-consecutive days with 2 sessions per day and 2 runs per session. A session was defined as a batch of multiple runs where each session was separated by at least two hours. A run was defined as a single instance of a sample being tested. Results were determined using three levels of hemolysate control samples (low = 1.4 U/gHb, medium = 7.0 U/gHb, high = 17.4 U/gHb) resulting in 84 replicates per level. The study was conducted on 3 instruments using 3 cartridge lots.
The reproducibility study was conducted at 3 sites using fresh whole blood samples that were prepared each of 5 days by appropriate dilution to obtain 3 target G6PD levels (low = 8.0 U/g Hb) per day. Each day aliquots at the three sample levels were delivered to each testing site, where they were subdivided into 8 samples that were evaluated on 2 instruments by 2 operators, with 2 replications each. A total of 15 samples (3 G6PD levels, prepared on each of 5 days) were evaluated, and each sample was measured by the FINDER Instrument 24 times (across 3 sites, 2 instruments, 2 operators per site, 2 replicates), resulting in a total of 360 measurements for analysis.
8
Results of the precision studies are shown below are shown in Table 2 and Table 3.
| Sample | N | Mean
(U/gH
b) | Between
Run
(%CV) | Between
Day
(%CV) | Between
Operator
(%CV) | Between
Lot (%CV) | Between
Instrument
(%CV) | Repeatability
(%CV) | Reproducibility
(%CV) |
|--------|----|---------------------|-------------------------|-------------------------|------------------------------|----------------------|--------------------------------|------------------------|--------------------------|
| Low | 84 | 1.4 | 3.2% | 0.7% | 0.0% | 0.0% | 3.8% | 4.1% | 6.5% |
| Inter. | 84 | 7.0 | 2.2% | 1.1% | 0.0% | 1.8% | 2.4% | 3.6% | 5.3% |
| High | 84 | 17.4 | 2.6% | 0.0% | 0.0% | 0.0% | 3.9% | 2.4% | 5.2% |
Table 2 – Summary of Single Site Precision Study
| Sample | N | Mean (U/gHb) | Between Site
(%CV) | Between
Instrument
(%CV) | Between
Operator
(%CV) | Repeatability
(%CV) | Reproducibility
(%CV) |
|--------|-----|--------------|-----------------------|--------------------------------|------------------------------|------------------------|--------------------------|
| Low | 120 | 1.1 | 0.0% | 0.9% | 0.0% | 5.9% | 6.0% |
| Inter. | 120 | 3.5 | 0.7% | 2.5% | 1.0% | 3.4% | 4.4% |
| High | 120 | 11.2 | 0.5% | 0.6% | 2.2% | 6.6% | 7.0% |
Table 3 – Summary of Reproducibility Precision Study
7.1.2. Linearity
Linearity was evaluated in accordance with CLSI EP06-A. Two separate studies were conducted to evaluate linearity. The first study was a full range linearity study that used contrived samples of recombinant G6PD enzyme spiked into whole blood to achieve activity levels that cover the intended linear range of the test. Nine samples were generated with increasing levels of G6PD activity from 2.0 to 19.7 U/gHb.
The second study was a native linearity study that used whole blood from a normal and G6PDdeficient donor. The native linearity study was performed to ensure that linearity demonstrated in the full range linearity study with contrived samples is not an artifact associated with usage of recombinant G6PD. Nine samples were generated with increasing levels of G6PD activity from 0.8 to 13.9 U/gHb.
The linear range for the FINDER G6PD test is given by the full range of both linearity studies. The FINDER G6PD test was demonstrated to be linear from 0.8 to 19.7 U/g Hb.
9
7.1.3. Interference
Interference was evaluated in accordance with CLSI EP07 3rd edition quidelines. Whole blood test samples were spiked with possible interfering substances at concentrations equal to or greater than the quidelines. Each whole blood sample was tested at two G6PD enzymatic activity levels: normal G6PD activity (>7 U/qHb) and near the medical decision level (MDL near 2 – 4 U/gHb). Spiked samples (test pools) were compared to control pool without the interfering substances.
Hematocrit values greater than 40% did not interfere with the G6PD test result. A bias of -15.3% was observed for a normal sample at 29% hematocrit (8.9 g/dL hemoqlobin on FINDER) as compared to the control pool of 50% hematocrit (15.3 g/dL hemoglobin on FINDER). A bias of -11.1% was observed for a sample near the medical decision level at 30% hematocrit (11.3 g/dL hemoqlobin on FINDER). as compared to the control pool of 50% hematocrit (15.3 g/dL hemoglobin on FINDER).
The following endogenous substances were found to be non-interfering at the maximum tested concentrations.
| Substance | Maximum Tested
Concentration |
|--------------------------|---------------------------------|
| Bilirubin | 50 mg/dL |
| Hemoglobin | 5 g/L |
| Intralipid | 1000 mg/dL |
| Glucose | 55 mM |
| Galactose | 1 mM |
| Copper | 0.150 mg/dL |
| Lactate | 90 mg/dL |
| Lactate
dehydrogenase | 6000 U/L |
Endogenous Substances:
The following common drugs were found to be non-interfering at the maximum tested concentrations.
Common Drugs
| Substance | Maximum Tested
Concentration |
|------------|---------------------------------|
| Ampicillin | 0.16 mM |
| Ibuprofen | 2.5 mM |
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7.1.4. Sensitivity
The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) for the FINDER G6PD test were evaluated in accordance with CLSI EP17-A2.
The LoB was evaluated using whole blood altered to a blank G6PD activity; the LoD was evaluated using whole blood at low G6PD activity; the LoQ was evaluated using four whole blood samples with increasing levels of G6PD activity prepared by spiking a blank pool with increasing concentrations of a normal pool.
The studies were conducted using 3 lots of FINDER G6PD Cartridges on 6 FINDER Instruments.
| Detection Capability | G6PD (U/g Hb) |
|---|---|
| Limit of Blank (LoB) | 0.2 |
| Limit of Detection (LoD) | 0.4 |
| Limit of Quantitation (LoQ) | 1.1 |
Table 6 - Sensitivity (LoB, LoD, LoQ)
Clinical Performance 8.
8.1. Method Comparison with Predicate Method
A clinical method comparison study was performed to demonstrate and compare the clinical performance of the FINDER Instrument and the FINDER G6PD Cartridge test to a comparator method using venous whole blood sample collected in lithium heparin tubes. The study design for this method comparison study was based on CLSI EP09-c – Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
Lithium heparinized whole blood samples from 200 subjects were analyzed on the FINDER Instrument across 6 collection sites. Whole blood samples were shipped to a central laboratory under refrigerated conditions to analyze using the comparator method.
The samples tested were collected from 6 sites including one biorepository. Subjects included 89 males and 92 females with ages ranging from 20 to 72 years. 19 contrived samples were included in the study
G6PD activity results were compared using a Deming Regression linear fit yielding an estimated slope of 0.92, an intercept of 0.28, and a correlation coefficient of 0.9. The slope, intercept, and correlation coefficient are shown in the table below.
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| Measurand | N | Range | Slope (95% CI) | Intercept (95% CI) | Correlation
Coefficient |
|-----------|-----|------------------|-------------------|--------------------|----------------------------|
| G6PD | 200 | 1.1 - 16.6 U/gHb | 0.92 (0.89, 0.95) | 0.28 (0.12, 0.44) | 0.9 |
The bias and percentage bias at the medical decision levels are shown in the table below
| MDLs | Bias (95% CI) | %Bias (95% CI) |
|---|---|---|
| 3.1 U/gHb (30% of AMM) | 0.0 U/gHb (-0.1, 0.2) | 1.4% (-2.5%, 5.4%) |
| 8.4 U/gHb (80% of AMM) | -0.4 U/gHb (-0.5, 0.2) | -4.3% (-6.5%, -2.0%) |
A concordance analysis was performed where the first 36 normal male samples were used to calculate the adjusted male median. The remaining 167 samples were used in the data analysis. The adjusted male median for the FINDER G6PD Test was 10.45 U/gHb. The adjusted male median for the Pointe Scientific G6PD test run on Cobas Mira was 10.88 U/gHb.
The following tables summarize the agreement between the FINDER G6PD Test and the Pointe Scientific Glucose-6-Phosphate Dehydrogenase Reagent Set on Cobas Mira) using different cutoffs. The results are presented as a percentage of the Adjusted Male Medium and include male, female, and contrived samples.
| | | Pointe Scientific Glucose-6-
Phosphate Dehydrogenase
Reagent Set on Cobas Mira | | | Total | Agreement | Wilson Score 95% CI | |
|------------------------|-----------|--------------------------------------------------------------------------------------|-----------|-------|-------|-----------|---------------------|--------|
| | | 70% | | | | |
| FINDER
G6PD
Test | 70% | 0 | 8 | 105 | 113 | 98.1% | 93.4% | 99.5% |
| | Total | 28 | 32 | 107 | 167 | 92.8% | 87.9% | 95.8% |
3 x 3 Contingency Table: 80% | | | | |
| FINDER
G6PD
Test | 80% | 0 | 11 | 89 | 100 | 93.7% | 86.9% | 97.1% |
| | Total | 28 | 44 | 95 | 167 | 88.6% | 82.9% | 92.6% |
2 x 2 Agreement Table 20.0 q/dL) on the FINDER can generate inaccurate results when a sample is not adequately mixed. Samples suspected of improper mixing should be retested using a new sample.
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13. Conclusion
The results drawn from the non-clinical tests presented in these 510(k) submissions demonstrate that the FINDER G6PD test is safe, effective, and performs as well as the legally marketed predicate device identified in this 510(k) summary.
1 E. Beutler, "G6PD Deficiency," Blood, vol. 84, no. 11, pp. 3613-3636, 1994.