(161 days)
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Based on the provided text, this device does not contain an AI model.
Here's why:
- No mention of AI, DNN, or ML: The text explicitly states "Mentions AI, DNN, or ML: Not Found".
- Mechanism of action is described as an immunoassay: The description details a chemical reaction involving antibodies and colloidal gold to detect CRP. This is a standard biological assay technique, not an AI process.
- No mention of image processing: While some rapid tests might use image processing for interpretation, this description states "Mentions image processing: Not Found". The result is described as a visible pink band.
- No description of training or test sets: AI models require training and testing data, which are completely absent from the description.
- Performance metrics are based on agreement with a reference assay: The performance studies compare the results of this rapid test to a commercially available ELISA, which is another type of immunoassay, not an AI system.
The BioCheck CRP Rapid Test is a traditional immunoassay that relies on the specific binding of antibodies to detect the presence of CRP.
No
The device is a diagnostic test for detecting C-reactive protein (CRP) to help evaluate infection, tissue injury, and inflammatory disorders; it does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "qualitative detection of C-reactive protein (CRP) in human serum" and that "Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases." This indicates its purpose in diagnosing or aiding in the diagnosis of various medical conditions.
No
The device description clearly indicates it is a physical immunoassay kit utilizing colloidal gold/antibody conjugate and a membrane for detection, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of C-reactive protein (CRP) in human serum." This indicates the device is used to test a biological sample (serum) outside of the body to provide information about a person's health status.
- Device Description: The description details a laboratory-based immunoassay using human serum samples and a chemical reaction (colloidal gold/antibody conjugate) to detect the presence of CRP. This is a typical characteristic of an in vitro diagnostic test.
- Sample Type: The device uses "human serum," which is a biological specimen.
- Purpose: The purpose is to aid in the "detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases," which are medical conditions.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DCN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Four laboratories were provided with blind serum samples that had been spiked with purified CRP. Five samples containing 1.0, 2.0, 3.0, 4.0, 5.0 mg/L of CRP and one negative control were prepared. Five blind replicates of each sample were tested in each laboratory for assay results. The assay results demonstrated 100% agreement between sites.
Interference: The following potentially interfering substances do not appear to interfere with the BioCheck CRP Rapid Test at the levels indicated below: Biotin (200 ng/mL), Bilirubin (10 mg/dL), Hemoglobin (200 mg/dL), Cholesterol (800 mg/dL), Triglyceride (1250 mg/dL). In vitro testing of common-used drugs (~10 µg/ml Final Concentration) also revealed no interference within the normal therapeutic range.
Hook Effect: When CRP standard of 200 mg/L was used for evaluation of hook effect, the test line appeared 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: Normal human serum was supplemented with purified human CRP to yield concentrations of 1.0, 2.0, 3.0, 4.0, and 5.0 mg/L. These samples 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.
Clinical Comparison: A total of 384 patient serum samples from three separate testing groups were tested with the BioCheck CRP Rapid Test and on a commercially available quantitative assay for CRP (BioCheck hsCRP ELISA).
Group #1 compared both devices on randomly selected patient samples.
Group #2 tested both the two devices on patient samples with elevated CRP values.
Group #3 tested both the two devices on patients with known disease status (e.g., inflammation, infection).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Based on the clinical cutoff of 4.0 mg/l, the positive agreement of the BioCheck CRP Rapid Test with the BioCheck predicate device was reported as 98.2%, while negative agreement ( 4 mg/L) was reported as 98.2% and overall negative agreement was 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%.
- 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%.
Predicate Device(s)
BioCheck hsCRP ELISA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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 | ||
| Acetylsalicylic acid | ||
| Adenine | ||
| Albumin (bovine) | ||
| Allopurinol | ||
| Ambroxol | ||
| Ampicillin | ||
| Ascorbic acid | ||
| Atenolol | ||
| Atropine | ||
| Caffeine | Captopril | |
| Chloramphenicol | ||
| Cinnarizine | ||
| Cyclophosphamide | ||
| Cyclosporine | ||
| Digitonin | ||
| Digoxin | ||
| Dopamine | ||
| Erythromycin | ||
| Gentistic acid | ||
| Isoproterenol | Isosorbide dinitrate | |
| Nifedipine | ||
| Nystatin | ||
| Oxazepam | ||
| Oxytetracycline | ||
| Propranolol | ||
| Theophylline | ||
| L-thyroxine | ||
| Urea | ||
| 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 ( ✓ | OR | Over the Counter Use: | __ |
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maria Chan
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K040030