(259 days)
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.
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 antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. 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, when it is used in accordance with the BinaxNOW® Malaria test product insert. 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 properly and the operator performed the test procedure correctly.
The provided text describes a 510(k) submission for the BinaxNOW® Malaria Positive Control, a quality control material, not a diagnostic device with performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design parameters for evaluating device performance against ground truth, and human-in-the-loop studies is not applicable to this type of submission.
The "performance summary" section details the stability and shelf life of the control material, which are the relevant performance characteristics for a quality control product.
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the Quality Control Material) | Reported Device Performance |
|---|---|
| Stability (Lyophilized, closed vial): | 5 months when stored at 2-8°C. |
| Stability (Reconstituted, open vial): | 5 months when stored at -20°C. |
Note: The primary "performance" of this device is its stability and its ability to consistently produce a positive result when run with the BinaxNOW® Malaria Test, which verifies the test's proper function.
2. Sample size used for the test set and the data provenance
Not applicable. This is a quality control material, not a diagnostic device evaluated against a patient test set. The "testing" referred to in the document is internal stability testing of the control material itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for diagnostic devices (e.g., disease presence) is not relevant for a quality control material. The "ground truth" for this control is its consistent positive reactivity.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, nor is it a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
For the BinaxNOW® Malaria Positive Control, the "ground truth" is its designed positive reactivity. When run on the BinaxNOW® Malaria Test, the control is intended to "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 control material is functioning as intended, and by extension, that the test reagents and operator procedure are correct.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an algorithm or diagnostic device for this quality control product.
9. How the ground truth for the training set was established
Not applicable.
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510(k) SUMMARY
, This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the st
requirements of SMDA 1990 and 21 CFR 807.92 requirements of STO(R) Salety and enectiveness in
requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K083744
SUBMITTER
Binax, Inc., d/b/a Inverness Medical 10 Southgate Road Scarborough, Maine 04074 (207) 730-5750 (General) (207) 730-5717 (FAX) Establishment Registration Number: 1221359
CONTACT PERSON
Anne Jepson anne.jepson@invmed.com (email)
DATE PREPARED
December 12, 2008
TRADE NAME
BinaxNOW® Malaria Positive Control
COMMON NAMES
BinaxNOW® Malaria Positive Control, Binax NOW® Malaria Positive Control, NOW® Malaria Positive Control
CLASSIFICATION NAME
Quality control material (assayed and unassayed), (per 21 CFR 862.1660)
PREDICATE DEVICE
Bio-Rad Laboratories (Blackhawk BioSystems, Inc.) CryptoTrol™, 510k exempt
DEVICE DESCRIPTION
The BinaxNOW® Malaria Positive Control is a recombinant antigen control control control control control control control HRP II (histidine-rich protein II), which is specific for Plasmodium falsparum (P.f.), and a pan-malaria (r. mixture of
HRP II (histidine-rich protein II), which is specific ( BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a
BinaxNOW® Malaria Positive Control can be used as a quality control sample repr positive test result and to verify proper performance of the procedure and reagents of a
malaria test, when it is used in accordance of the procedure and reagents of the Bina r and read in and to vonly proper performance of the procedure and reagents of the BinaxN
Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product
The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized
water. The reconstituted control is then added to a pool of proc water. The reconstituted control is then added to a pool of presimed negative EDTA his deinized
water. The reconstituted control is then added to a pool of presented for a blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Maria Test, thuman whole
control should always generate on both the BinaxNOW® Malaria Test, the positiv control should always while results on both the P.f. specific (HRP In positive positive
control should always generate positive results on both the P.f. specific (HRP II) tes pan mala in and on the positive results on both the P.f. specific (HR II) test line and on the end on the e
pan malarial test line. This demonstrates that the test reagents operator performed the test procedure correctly.
BinaxNOW® Malaria Positive Control 510(k) Notification
SEP - 1 2009
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INTENDED USE
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOV® Malaia Test. It is designed for routine external quality
control with the qualitative BinaxNOV® Malaia Test. It is designed for routine proper performance of the procedure and the anigen detection reagents of the BinaxNOW waland
Test.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE
The BinaxNOW® Malaria Positive Control and the predicate Bio-Rad Laboratories (Blackhawk
BioSystems, Inc.) CryptoTrol™ utilize different mattes Bio-Rad ( control and commans antigens and is supplied in liquid form - Bio-Rad Chille i Politic Polliw i Politic
control utilizes purfied C. neoformans antis supplied in liquid form. in qualitative antigen detection tests for quality control purposes.
PERFORMANCE SUMMARY
Stability Studies have been performed to determine the stability and shelf life of the BinaxNOW®
Malaria Positive Control in both its lyobhilized (closed viel) form and it Product claims are as follows:
Lyophilized (closed vial) form: 5 months when stored at 2-8°C.
Reconstituted (open vial) form: 5 months when stored at -20°C.
Real time studies will be on-going to support and extend the shelf-life of this product.
Signed Pamela S. Angell Date 12/12/08
Pamela Angell
VP, Regulatory Affairs North America
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Ms. Anne Jepson Manager, Clinical Affairs Binax, Inc. Inverness Medical Innovations, Inc. 10 Southgate Road Scarborough, ME 04074
SEP - 1 2009
Re: K083744
Trade/Device Name: Binax NOW® Malaria Positive Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Class: Class I Product Code: MJZ Dated: July 30, 20095 Received: August 4, 2009
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
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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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally A. Hoivat, M Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
cc: HFZ-401 DMC -HFZ-404 510(k) Staff HFZ- D.O.
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INDICATIONS FOR USE STATEMENT
28574 510(k) Number (if known): _
Device Name: BinaxNOW® Malaria Positive Control
Indications for Use:
The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality
control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition
Test.
Prescription Use V Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leddi Mc. Rady
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
BinaxNOW® Malaria PSsM(K)Control 510(k) Notification
Revision 12/12/08
12
083744
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.