BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

{0}------------------------------------------------ ## BioCheck, Inc. ### CRP RAPID TEST For the qualitative detection of C-reactive protein (CRP) in human serum. #### MANUFACTURER: 1. BioCheck, Inc. 323 Vintage Park Drive Foster City, CA 94404 (650) 573-1968 Phone: (650) 573-1969 Fax: Hellen Professional Services Requiatory Contact: (818) 709-5646 Phone: #### DEVICE NAME and CLASSIFICATION: 11. | Proprietary Name: | BioCheck Rapid C-Reactive Protein Test Kit | |----------------------|---------------------------------------------------------| | Catalog Number: | 804114 | | Common Name: | BioCheck CRP Rapid Test | | Classification Name: | C-reactive Protein Immunological Test System (866.5270) | #### INTENDED USE and ASSAY PRINCIPLE: lll. The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed fine bloomoon of CRP in human serum samples. To perform the serum CRP test, serum is for the detection of ORF in haman ocrait in the specimen is bound by a gold-antibody unspectoruline the Sumple Woll. Ontigen complex. This complex migrates across the membrane by conjugate roming a gota anti-human CRP polyclonal antibody immobilized in the test capitaly action and route the CRP concentration is equal to or greater than 4.0 mg/L. region to produce a pink color band whon the ord "concent there is no line in the test line area. The II Gru-continues to migrate to the control line area and produce a pink color band, indicating a valid test. #### SUBSTANTIAL EQUIVALENCE: IV. The BioCheck CRP Rapid Test is substantially equivalent to the BioCheck hsCRP ELISA currently The DioGheck Ord "Tupid Tool is bubtantialy Aquin Both assays are used for the qualitative or quantitative (BioCheck ELISA) detection of CRP in human serum. {1}------------------------------------------------ #### TEST PERFORMANCE: V. #### Precision 1. Precision Four laboratories were provided with blind serum samples that had been spiked with burified Four laboratories were provided with blind series and CRP were prepared. Five blind CRP. Five samples containing 1.0, 2.0, 5.0, 4.0, 4.0, 4.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, 1.0, replicates of each sample were lested in odon the for essay results demonstrated 100% were also "lested" in "manaractare of (abon) agreement between sites. #### 2. Interference The following potentially interfering substances do not appear to interfere with the The following potentially intononing oubotances as a to the levels indicated below: | Analyte | Test Level | |--------------|------------| | Biotin | 200 ng/mL | | Bilirubin | 10 mg/dL | | Hemoglobin | 200 mg/dL | | Cholesterol | 800 mg/dL | | Triglyceride | 1250 mg/dL | In vitro testing of the following common-used drugs revealed no interference within the normal therapeutic range: | Analyte (~10 µg/ml Final Concentration) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Acetaminophen<br>Acetylsalicylic acid<br>Adenine<br>Albumin (bovine)<br>Allopurinol<br>Ambroxol<br>Ampicillin<br>Ascorbic acid<br>Atenolol<br>Atropine<br>Caffeine | Captopril<br>Chloramphenicol<br>Cinnarizine<br>Cyclophosphamide<br>Cyclosporine<br>Digitonin<br>Digoxin<br>Dopamine<br>Erythromycin<br>Gentistic acid<br>Isoproterenol | Isosorbide dinitrate<br>Nifedipine<br>Nystatin<br>Oxazepam<br>Oxytetracycline<br>Propranolol<br>Theophylline<br>L-thyroxine<br>Urea<br>Uric acid | #### Hook Effect 3. When CRP standard of 200 mg/L was used for evaluation of hook effect, the test line which one of after 5 minutes. Thus, there is no hook effect if CRP concentration in patient serum sample is equal to or below 200 mg/L. #### Recovery Study 4. Normal human serum was supplemented with purified human CRP to yield concentrations of Normal haman Soran was odiplioms were tested in six replicates using the BioCheck CRP Rapid Test. The data showed 100% agreement between the expected and the observed results at each CRP concentration. {2}------------------------------------------------ #### TEST PERFORMANCE: V. #### Clinical Comparison 5. A total of 384 palient serum samples from three separate testing groups were tested with A total of 304 patient serials some in the on a commercially available quantitative assay for CRP (BioCheck hsCRP ELISA). Group #1 compared both devices on randomly selected patient samples and Group #2 tested both the two devices on patient samples with elevated CRP values. Lastly, Group #3 tested both the wo devices on patients with known disease status (e.g., inflammation, infection). Based on the clinical cutoff of 4.0 mg/l, the positive and negative agreement of the BioCheck Dased on tire cimical cuton of 4.0 mgn, the BioCheck predicate device. Overall positive One Rapid Test Was oonpared as 98.2%, while negative agreement (< 4 mg/L) was agreement (2 + ThgrL) was Toponod as '60hbho' veach group were as follows'. calculated at 96.3%. Individual agreements observed in each group were as follows: - Group #1: Positive Agreement = 97.2%, Negative Agreement = 97.1%, Overall . Accuracy = 97.1%. - Accuracy = 37.17%. Group #2: Positive Agreement = 98.6%, Negative Agreement = 94.7%, Overall . Accuracy = 96.6%. - Positive Agreement = 100%, Negative Agreement = 100%, Overall Group_#3: . Accuracy = 100%. Revision Date: 05-21-04 {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN 1 6 2004 Biocheck, Inc. c/o Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325 k040030 Re: Trade/Device Name: BioCheck, Inc. CRP Rapid Test Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: May 4, 2004 Received: May 10, 2004 Dear Ms. Hellen: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) {{ itg======================================================================================================================================= connineses prior to May 20, 2978, as econdance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costicule Hory (1 tot) that to neview subject to the general controls provisions of the Act. The I ou may, merelore, manel af the Act include requirements for annual registration, listing of general controls provisions of the recess 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 If your deview is elabilional controls. Existing major regulations affecting your device can may be subject to such additional combegulations (CFR), Parts 800 to 895. In addition, FDA be found in The Layers, announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DA 3 lisualled or our device complies with other requirements of the Act that I Dri has made a acterimalations administered by other Federal agencies. You must of any I catal stututes und regulatients, including, but not limited to: registration and listing (21 Comply with an the Free Frequirements 801 and 809); and good manufacturing practice CI It I art 807), labeling (in the quality systems (QS) regulation (21 CFR Part 820). {4}------------------------------------------------ ### Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ finding of substantial equivalence of your device to a legally prematication. The PDF mining of castification 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, If you desire spoolite missing of your device, please contact the Office of or questions on the promise Evaluation and Safety at (301) 594-3084. Also, please note the In vir o Diagiostic Devilostic by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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 vours, Joseph L. Hackett Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # STATEMENT FOR INDICATIONS FOR USE | 510(k) Number (if known): | K040030 | |---------------------------|-------------------------------| | Device Name: | BioCheck, Inc. CRP Rapid Test | Indications for Use: The *BioCheck CRP Rapid Test* is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Concurrence of the CDRH, Office of Device Evaluation (ODE) | Prescription Use: | <div> ✓ </div> | OR | Over the Counter Use: | <div> __ </div> | |-------------------|--------------------------------------------|----|-----------------------|---------------------------------------------| |-------------------|--------------------------------------------|----|-----------------------|---------------------------------------------| maria Chan Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040030