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.

Device Description

The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed for the detection of CRP in human serum samples. To perform the serum CRP test, serum is added to the Sample Well. CRP in the specimen is bound by a gold-antibody conjugate forming a gold-antigen complex. This complex migrates across the membrane by capillary action and reacts with a goat anti-human CRP polyclonal antibody immobilized in the test region to produce a pink color band when the CRP concentration is equal to or greater than 4.0 mg/L. If the CRP concentration is less than 4.0 mg/L, there is no line in the test line area. The gold-conjugate continues to migrate to the control line area and produce a pink color band, indicating a valid test.

AI/ML Overview

BioCheck CRP Rapid Test Study Analysis

Here's a breakdown of the acceptance criteria and the study proving the BioCheck CRP Rapid Test meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Precision	100% agreement between multiple testing sites for various CRP concentrations.	Four laboratories tested blinded serum samples spiked with purified CRP at 5 concentrations (1.0, 2.0, 5.0, 4.0 mg/L - note: the document lists 4.0 thrice and 1.0 five times, which seems like a typo, assuming 5 distinct concentrations were intended for the 5-sample set). Five replicates of each sample were tested. The results demonstrated 100% agreement between sites.
Interference	No interference from specified endogenous substances and common-used drugs at predefined levels.	The following potentially interfering substances showed no interference: Biotin (200 ng/mL), Bilirubin (10 mg/dL), Hemoglobin (200 mg/dL), Cholesterol (800 mg/dL), Triglyceride (1250 mg/dL). In addition, no interference was observed from a long list of common-used drugs (~10 µg/ml final concentration) within their normal therapeutic ranges.
Hook Effect	No hook effect up to a specified high CRP concentration.	When a CRP standard of 200 mg/L was used, the test line appeared within 5 minutes, indicating no hook effect if the CRP concentration in the patient serum sample is equal to or below 200 mg/L.
Recovery	100% agreement between expected and observed results for fortified samples at various CRP concentrations.	Normal human serum was supplemented with purified human CRP at 5 concentrations (numbers not specified, but implied to be distinct from the precision study). These samples were tested in six replicates. The data showed 100% agreement between the expected and the observed results at each CRP concentration.
Clinical Comparison	High positive, negative, and overall agreement with a commercially available quantitative predicate assay (BioCheck hsCRP ELISA) at a 4.0 mg/L cutoff.	The BioCheck CRP Rapid Test was compared to the BioCheck hsCRP ELISA. Overall Positive Agreement (>= 4 mg/L) = 98.2% Overall Negative Agreement (< 4 mg/L) = 96.3% Individual group results: - Group #1: Positive Agreement = 97.2%, Negative Agreement = 97.1%, Overall Accuracy = 97.1%. - Group #2: Positive Agreement = 98.6%, Negative Agreement = 94.7%, Overall Accuracy = 96.6%. - Group #3: Positive Agreement = 100%, Negative Agreement = 100%, Overall Accuracy = 100%.

2. Sample Size for Test Set and Data Provenance

Sample Size for Clinical Comparison (Test Set): A total of 384 patient serum samples were used.
Data Provenance: The document does not explicitly state the country of origin. It indicates retrospective testing of patient serum samples, as they were "patient serum samples from three separate testing groups." The study was conducted by BioCheck, Inc. in Foster City, CA, suggesting the data is likely from the USA, but it's not explicitly stated for the patient samples themselves.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the use of "experts" to establish ground truth for the test set. The ground truth for the clinical comparison was established by a predicate device: a commercially available quantitative assay for CRP (BioCheck hsCRP ELISA). Therefore, no information on the number or qualifications of human experts is provided for this study.

4. Adjudication Method for the Test Set

Since the ground truth was established by a quantitative laboratory assay (BioCheck hsCRP ELISA) rather than human interpretation, there was no adjudication method described or necessary in the traditional sense (e.g., 2+1, 3+1). The results of the rapid test were directly compared to the numerical results of the predicate ELISA assay against a defined clinical cutoff.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This study evaluates a rapid diagnostic test (BioCheck CRP Rapid Test) against a laboratory-based quantitative assay, not human readers with or without AI assistance. The BioCheck CRP Rapid Test is a qualitative, immunoassay-based device that gives a visual result (pink color band), not an AI-driven imaging interpretation system.

6. Standalone (Algorithm Only) Performance

This question is not entirely applicable in the context of this device. The BioCheck CRP Rapid Test is a standalone diagnostic device in the sense that its performance, as described in the "Clinical Comparison" section, is the performance of the device itself (the qualitative rapid test) without a human-in-the-loop for interpretation beyond simply observing the presence or absence of a line. There is no "algorithm only" component separate from the physical test strip and its chemical reactions. The performance metrics presented (positive and negative agreement) are those of the device in its intended use.

7. Type of Ground Truth Used (Clinical Comparison)

The ground truth used for the clinical comparison was the results from a commercially available quantitative predicate assay for CRP (BioCheck hsCRP ELISA). This is a laboratory-based assay providing a numerical CRP concentration, which was then compared to the qualitative result of the rapid test based on a clinical cutoff of 4.0 mg/L.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" for an algorithm. This type of rapid test is based on immunoassay principles, not machine learning algorithms that typically require training data. The development and validation likely involved internal development studies (e.g., optimizing antibody concentrations, membrane properties) rather than algorithmic training on a labeled dataset. The studies described (precision, interference, hook effect, recovery) are more akin to verification and validation tests for a chemical-based assay.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" or an algorithm that requires training, this information is not applicable and is not provided in the document. The device's mechanism is based on antigen-antibody reactions, not a trained algorithm.

Summary

{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 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)
AcetaminophenAcetylsalicylic acidAdenineAlbumin (bovine)AllopurinolAmbroxolAmpicillinAscorbic acidAtenololAtropineCaffeine	CaptoprilChloramphenicolCinnarizineCyclophosphamideCyclosporineDigitoninDigoxinDopamineErythromycinGentistic acidIsoproterenol	Isosorbide dinitrateNifedipineNystatinOxazepamOxytetracyclinePropranololTheophyllineL-thyroxineUreaUric 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:	✓	OR	Over the Counter Use:	__
-------------------	--------------------------------------------	----	-----------------------	---------------------------------------------

maria Chan

Division Sign-Off

Office of In Vitro Diagnostic

Device Evaluation and Safety

510(k) K040030

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).