BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

K083744 · Binax, Inc. · MJZ · Sep 1, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083744
• Device Name: BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
• Applicant: Binax, Inc.
• Product Code: MJZ · Clinical Chemistry
• Decision Date: Sep 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malaria Test. It is designed for routine use to aid in verifying proper performance of the procedure and the antigen detection reagents of the BinaxNOW® Malaria.

Device Story

BinaxNOW® Malaria Positive Control; lyophilized recombinant antigen mixture containing HRP II (Plasmodium falciparum specific) and pan-malarial protein. Reconstituted with deionized water; added to presumed negative EDTA human whole blood. Used as external quality control for BinaxNOW® Malaria Test (qualitative immunochromatographic assay). Operator performs test procedure; observes Control (C) line and T1/T2 test lines. Positive result confirms reagent functionality and correct procedural execution. Used in clinical laboratory settings; aids in verifying assay performance.

Clinical Evidence

No clinical data. Stability studies were performed to determine shelf life for lyophilized (5 months at 2-8°C) and reconstituted (5 months at -20°C) forms.

Technological Characteristics

Recombinant antigen control containing HRP II and pan-malaria antigen mixture. Supplied as a lyophilized powder for reconstitution with deionized water. Intended for use with human whole blood. Class I device (21 CFR 862.1660).

Indications for Use

Indicated for use as an assayed positive external quality control for the BinaxNOW Malaria Test to verify proper performance of the procedure and antigen detection reagents.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Bio-Rad Laboratories Cryptrol (Exempt Device)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k083744

B. Purpose for Submission:
510(k) clearance for a Positive Control for a previously cleared assay

C. Measurand:
Recombinant Plasmodium antigens

D. Type of Test:
Qualitative, in vitro immunochromatographic assay

E. Applicant:
Binax, Inc., d/b/a Inverness Medical

F. Proprietary and Established Names:
Binax NOW® Malaria Positive Control

G. Regulatory Information:
a) Regulation section:
21 CFR 862.1660
Quality control material (assayed and unassayed)

b) Classification:
Class I

c) Product Code:
MJZ

d) Panel:
83 Microbiology

H. Intended Use:
1. Intended use:
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malaria Test. It is designed for routine use to aid in verifying proper performance of the procedure and the antigen detection reagents of the BinaxNOW® Malaria.

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2. Indications for use:
The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria Test.

3. Special condition for use statement(s):
The device is for prescription use only

4. Special instrument Requirements:
NA

I. Device Description:
The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial protein. The source of the cloned nucleic acid regions was Plasmodium falciparum DNA.

J. Substantial Equivalence Information:
The BinaxNOW® Malaria Positive Control is an accessory to the BinaxNOW® Malaria Test.

Predicate Device: Bio-Rad Laboratories Cryptrol
510(k) Number: Exempt Device

K. Standard/Guidance Document Referenced (if applicable):
N/A

L. Test Principle:
The BinaxNOW® Malaria Positive Control is intended to be used as a qualitative positive control sample in accordance with the BinaxNOW® Malaria Test product instructions. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f. specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working as expected and that the operator performed the test procedure correctly.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
A study was conducted at three sites to evaluate the inter-site and intra-site performance of two different lots of BinaxNOW® Malaria Positive Control.

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There was 100% agreement (36/36) agreement with the expected results, with no differences between lots, days, operators or sites.

b. Linearity/assay reportable range:
N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The sponsor studies support the stability of lyophilized control as well as the reconstituted lyophilized vial when stored at 2-8°C for six months..

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
N/A - Quality Control Material
a. Clinical Sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:

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## Positive Control Result:

The BinaxNOW® Malaria Positive Control should generate a positive result when used as directed (the Control (C) Line and both the T1 and the T2 lines must be visible in the result window of the BinaxNOW® Malaria test). Note that the appearance of any Test Line, even when very faint, indicates a positive result.

## Negative Control Result:

The negative control pool should generate a negative result when used as directed (only the Control (C) Line is visible in the result window).

## N. Proposed Labeling

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

## O. Conclusion:

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