ANEMIAPRO SELF-SCREENER

K042379 · Biosafe Laboratories, Inc. · KHG · Dec 15, 2004 · Hematology

Device Facts

• Record ID: K042379
• Device Name: ANEMIAPRO SELF-SCREENER
• Applicant: Biosafe Laboratories, Inc.
• Product Code: KHG · Hematology
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7500
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.

Device Story

AnemiaPro™ Self-Screener is a single-use, disposable kit for home-based hemoglobin testing. Input: self-collected capillary whole blood sample. Operation: blood sample is placed in a self-contained plastic housing containing a nitrocellulose-based test strip; device utilizes blood cell separation principles; plasma migrates through the strip; migration front is visualized via impregnated dye. Output: plasma migration distance, which is linearly and inversely proportional to hemoglobin concentration. The user reads the result based on migration distance. The device enables individuals to screen for anemia without professional assistance. Kit includes testing unit, lancets, alcohol prep pad, gauze, bandage, and instructions.

Clinical Evidence

Clinical trials conducted at three geographical sites compared self-collected capillary samples to professionally collected capillary samples and venous blood samples (analyzed via predicate methods). Performance characteristics evaluated included precision, linearity, analytical accuracy, correlation, and effects of interferences and environmental factors.

Technological Characteristics

Single-use disposable lateral flow device. Materials: Nitrocellulose membrane, plastic housing, porcine sodium heparin (~6 U), Tween 80®. Principle: Microporous membrane separation of RBCs from plasma; migration distance inversely proportional to hemoglobin concentration. Reportable range: 8–15 g/dL. Manual operation; no electronic components or software. Quality control: Built-in indicator dye window for sample volume verification.

Indications for Use

Indicated for over-the-counter determination of hemoglobin concentration in self-collected capillary whole blood samples. Not for use in neonates.

Regulatory Classification

Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Cell Dyn 3700 Analyzer, Abbott Laboratories, Inc.
• HemoCue B-Hemoglobin Instrument, HemoCue, Inc.

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number: #K042379
B. Purpose for Submission: New Over-the-counter (OTC) device
C. Manufacturer and Instrument Name: Applied Tech Products, LLC; BioSafe® Laboratories, Inc. AnemiaPro™ Self-Screener Hemoglobin Test Kit
D. Type of Test or Tests Performed: Quantitative hemoglobin test

E. System Descriptions:

1. Devise Description: The AnemiaPro™ Self-Screener device contains a single, unit-use disposable meter, enclosed in a foil pouch. It is a self-contained nitrocellulose based test strip, in plastic housing, that is divided into sections that read from 8 – 15 g/dL. It has an application membrane that contains a green indicator dye; and a quality control indicator adjacent to the fill port. The device also has an injection plunger, coated with a dilute solution of porcine sodium heparin (~ 6 U) to inhibit coagulation, and Tween 80® in a methanol and water base (to facilitate blood flow through the migration path). The kit also includes sterile alcohol, gauze pads and adhesive bandages; disposable safety lancets; a Transport Bag; and specimen collection instructions.

2. Principles of Operation: Red blood cells (RBC’s) are separated from a sample of capillary whole blood by a microporous membrane (a separation matrix) designed for lateral flow assays to produce plasma. The nitrocellulose membrane, with open pore structure, allows efficient flow of viscous liquids. The membrane alters the flow of RBC’s through the matrix, such that the lateral flow rate of plasma is greater than that of the RBC’s. The amount of plasma generated is dependent upon the red cell mass (hematocrit) of the sample. A green dye is added to the membrane prior to separation of the whole blood, so that the plasma retains the color and becomes visible. The plasma migrates through the test strip, such that low hemoglobin allows more plasma (and high hemoglobin allows less plasma) to be separated from the whole blood sample. More plasma generates further migration distance; less plasma generates a shorter migration distance from the membrane. Therefore, migration distance is linear and inversely proportional to the hemoglobin concentration.

3. Modes of Operation: Manual, hand-held meter.

4. Specimen Identification: A single 50 uL drop of capillary whole blood is required for a 15 uL sample to charge the test strip.

{1}

5. Specimen Sampling and Handling: The fingerstick capillary sample is manually collected.

6. Calibration: The meter is precalibrated to predetermined whole blood hemoglobin concentrations, over the reportable range of 8 – 15 g/dL. Pointe Scientific Hemoglobin Calibrator (#K851432) and the Roche Modular Analyzer (#K953239), a HiCN method, were used in the calibration procedures.

7. Quality Control: There is a built-in quality control window, with an indicator dye, to assure that an adequate whole blood sample has been delivered from the application plunger to the test strip membrane. No color change indicates that an insufficient blood sample was added to the test strip.

8. Software: N/A

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:

Yes _______ or No _______

F. Regulatory Information:

1. Regulation section: 21 CFR 864.7500 – Whole Blood Hemoglobin Assays
2. Classification: Class II
3. Product code(s): KHG – Whole Blood Hemoglobin Determination; GIG – Hemoglobinometer
4. Panel: Hematology (81)

G. Intended Use:

1. Indication(s) for Use: The AnemiaPro™ Self-Screener is intended for OTC distribution, for the determination of hemoglobin concentration in a self-collected whole blood sample. The device is not intended for use in neonates.
2. Special Conditions for Use Statement(s): Over-the-counter (OTC); contraindicated for use in patients < 18 years of age.

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers: Abbott Laboratories, Inc. Cell-Dyn Hematology Analyzer (#K955715); HemoCue, Inc. β-Hemoglobin Analyzer (#K961312).

2

{2}

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The AnemiaPro device is for quantitative determination of hemoglobin in whole blood (WB). | The HemoCue β-Hemoglobin Meter has the same intended use. |
| Sample type | Capillary WB | Same |
| Mode | Hand-held | Same |
| Endpoint reading | ≤ 30 minutes | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Technology | Lateral flow membrane separation of red blood cell mass from plasma | Colorimetric (modified Drabkins) |
| Sample types | Capillary WB | Capillary or venous WB |
| Reagents | None | Self-contained within cuvettes |
| Mode | Manual | Semi-automated |
| Reportable range | 8 – 15 g/dL | 0 – 25 g/dL |

I. Special Control/Guidance Document Referenced (if applicable): ODE Guidance Document, Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVD’s); and NCCLS Documents:

1. H4-A3, Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens by Skin Puncture, Approved Standard – 3rd Edition.
2. GP10-A, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristics (ROC) Plots; Approved Guideline.
3. EP7-P, Interference Testing in Clinical Chemistry; Proposed Guideline.
4. EP9-A, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, 2nd Edition.

{3}

5. EP5-T2, Evaluation of Precision Performance of Clinical Chemistry Devices; 2nd Edition.
6. EP12-A, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, 2nd Edition.
7. Procedures for the Handling and Transport of Diagnostic Specimens and Etiologic Agents; Approved Standard, 3rd Edition.
8. EP6-A, Evaluation of the Linearity of Quantitative Analytical Methods.

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy: The AnemiaPro (Anemia Meter) was compared to a HiCN-based photometric reference method and the Cell-Dyn Analyzer on patient samples (N=40), over the reportable range of 8 – 15 g/dL. Regression statistics were:

| HiCN | Cell-Dyn |
| --- | --- |
| y = 0.9153x + 0.5549 | y = 0.9759x – 0.2935 |
| r = 0.969; R2 = 0.9389 | r = 0.931; R2 = 0.8664 |

b. Precision/Reproducibility: Within-run precision was determined using replicates (N = 5) tested on (3) hemoglobin levels over the range of the meter. Results ranged from 4.8 – 6.0 % CV.

Between-run precision was also determined using replicates (N = 5), but were tested over a period of (4) days to give a total of (N = 20). Results ranged from 5.1 – 6.0 % CV.

c. Linearity: Metered venous blood (N = 26), with predetermined hemoglobin concentrations, was allowed to migrate to endpoint, between 8 – 15 g/dL on (2) devices. Hemoglobin values, ranging 8.7 – 15.3 g/dL were plotted against migration distances between 23.7 – 5.1 mm. Results yielded this inverse linear regression equation: y = -2.6851x + 45.551; R2 = 0.9487.

d. Carryover: N/A

e. Interfering Substances: Interference studies were performed on (4) replicates, each of lipids, bilirubin, hemoglobin (free), and protein (viscosity). Six standard dilutions of these substances were tested. Studies demonstrated there was no interference for lipids up to 600 mg/dL; for bilirubin, up to 40 mg/dL; for hemoglobin, up to 13.3 g/dL; and for protein, between 5 – 15 g/dL.

4

{4}

2. Other Supportive Instrument Performance Data Not Covered Above: An analytical accuracy and specificity study was done on males (< and ≥14.0 g/dL) and females (< and ≥12.0 g/dL). The results showed 96.3% analytical specificity /95.9% accuracy for males; and 98.9% specificity/97.1% accuracy for females. Overall specificity = 97.7%; and accuracy = 96.4%. The study was done on capillary samples with the Anemia Meter vs venous blood on the Cell Dyn device.

Clinical studies were performed at (3) sites, located in Chicago, IL, Denver, CO and Tucson, AZ on lay user samples (N = 224). A series of comparison studies were performed between the Anemia Meter, the Cell-Dyn and HemoCue devices over a range of 5.9 – 18.2 g/dL. These significant data were generated when the Anemia Meter (capillary self-testing) was compared to:

a. Cell-Dyn (venous professional testing)
Slope = 0.924; Intercept = 1.082; CC = 0.929
b. HemoCue (capillary self-testing)
Slope = 0.674; Intercept = 4.190; CC = 0.735
c. Anemia Meter (capillary professional)
Slope = 0.890; Intercept = 1.490; CC = 0.945

Out of a total of (267) untrained lay user participants, 265 (99.2%) successfully self-collected a blood sample; and 224 had successful test outcomes (84.8%)

Sample environmental studies (test strip position; temperature/humidity; plunger depression) were performed. Endpoint studies were also done to support a stability of (1) month from the testing date.

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

5