K Number

Device Name

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

Manufacturer

BIOCHECK, INC.

Date Cleared

2004-12-17

(185 days)

Product Code

MMI

Regulation Number

862.1215

Intended Use

The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test İs intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Device Description

The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is a colloidal gold/antibody conjugatebased immunoassay designed for the detection of cTnl in human whole blood, plasma and serum samples. To perform the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test, the sample is dispensed into the sample well. The red cells in the whole blood will react with certain biochemical reagents (such as anti-red blood cells) which are immobilized in the sample pad. This reaction will cause the red blood cells to bind to the sample pad, allowing only the plasma to travel forward. CTnl that is present in the specimen is bound by a gold-antibody conjugate forming a gold-antibody-antigen complex. This complex migrates across the membrane by capillary action and reacts with three anticTnl monoclonal antibodies immobilized in the test region to produce a pink color band when the cTnl concentration is equal to or greater than 1.5 ng/ml. If cTnl is not present in the specimen, there is no line in the test line area. The mixture continues to migrate to the procedural control line area and produce a pink color band. If no procedural control line is present, the sample is invalid and should be retested.

More Information

Contact

Type

Center

Panel

Date Received

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Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K023505

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunoassay based on colloidal gold and antibody conjugates, which relies on chemical reactions and capillary action to produce a visual result (color bands). There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies focus on traditional analytical and clinical validation metrics for an immunoassay.

Therapeutic

No.
This device is an in-vitro diagnostic test used for the qualitative determination of cardiac troponin I, which is useful in the evaluation of acute myocardial infarction. It provides diagnostic information but does not actively treat or mitigate a disease or condition.

Diagnostic

Yes

The device qualitatively determines cardiac troponin I in human samples, which is useful in the evaluation of acute myocardial infarction (AMI). This indicates its use in identifying a disease state, thus making it a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical immunoassay test that uses chemical reactions and a test strip to detect cardiac troponin I. This involves hardware components and chemical reagents, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative determination of cardiac troponin I in human whole blood, plasma or serum." This involves testing biological samples in vitro (outside the body) to provide information about a patient's health status (evaluation of acute myocardial infarction).
Device Description: The description details a laboratory-based immunoassay process using biological samples (whole blood, plasma, serum) and reagents to detect a specific analyte (cTnl). This is a hallmark of IVD devices.
Clinical Comparison and Performance Studies: The document includes performance data based on testing human samples (serum, whole blood) and comparing results to a predicate device and patient status. This type of testing and validation is required for IVD devices.
Predicate Device: The mention of a predicate device (K023505; BioCheck Serum Troponin I Rapid Test) which is also an IVD, further supports that this device falls under the IVD category.

Therefore, based on the provided information, the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is clearly an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Product codes (comma separated list FDA assigned to the subject device)

MMI

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:

Serum Samples: Four labs tested blind serum samples spiked with purified complex cTnl (0, 1.5, and 3.0 ng/ml). Five blind replicates of each sample were tested per site (total 15 tests per site), plus testing by the manufacturer. Results showed 100% agreement in between-run proficiency and between sites.
Whole Blood Samples: Four labs tested blind whole blood samples spiked with purified complex cTnl (0, 1.5, and 3.0 ng/ml). Five blind replicates of each sample were tested per site (total 15 tests per site), plus testing by the manufacturer. Results showed 100% agreement in between-run proficiency and between sites.

Recovery Study:

Samples (serum and whole blood) were spiked with partially purified human cTnl complex to yield concentrations of 0, 0.5, 1.0, 1.5, and 3.0 ng/ml.
Six replicates were tested for each spiked concentration using the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test.
Data showed 100% agreement between expected and observed results for both serum and whole blood samples.

Interference Study:

Potentially interfering substances: Biotin, Bilirubin, Hemoglobin, Rabbit skeletal muscle Troponin C, Human cardiac Troponin T, Human muscle Troponin T, Human muscle Troponin I, Cholesterol, Triglyceride were tested up to specified levels. No interference was observed.
Common-used drugs: 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 were tested. No interference was observed at the upper level of their therapeutic range.

Clinical Comparison (Clinical correlation study):

Sample Size: 245 patient serum samples.
Comparison: Results were compared with a commercially available quantitative ELISA assay for cTnl.
Results:
- Sensitivity = 73 / 75 = 97.3%
- Specificity = 165 / 170 = 97.1%
- Overall Accuracy = 238 / 245 = 97.1%

Correlation Study between Whole Blood and Plasma Samples:

Sample Size: 68 patient whole blood samples. Plasma was isolated from these samples.
Method: Paired whole blood and plasma samples were tested.
Agreement: 100% agreement (68/68) between whole blood and plasma tests.

Clinical Studies - Confirmed MI Patients:

Sample Size: 24 whole blood specimens from confirmed MI patients.
Comparison: Tested with the BioCheck Whole Blood/Plasma/Serum cTn1 Rapid Test and BioCheck cTnJ ELISA..Test.
Agreement: 23 out of 24 (95.8%) showed positive test results, agreeing with patient status.

Clinical Studies - Non-MI Patients:

Sample Size: 44 whole blood specimens from non-MI patients.
Comparison: Tested with the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test and the BioCheck cTnl ELISA Test.
Agreement: 100% agreement (44/44) with negative results obtained for both protocols.

Correlation of Assay Results Between Whole Blood and Serum Samples:

Sample Size: 20 individuals, with paired whole blood (WB) and serum (S) samples collected from each.
Method: Samples were spiked with the same amount of purified complex cTnl (17 samples ≥ 1.5 ng/ml, 3 samples

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.

Summary

BioCheck, Inc. DEC 17 2004

CARDIAC- 1 RAPID TEST

FOR THE QUALITATIVE DETERMINATION OF CARDIAC TROPONIN I In Human Whole Blood, Plasma or Serum

Catalog No.: 850116

MANUFACTURER: t.

BioCheck, Inc. 323 Vintage Park Drive Foster City, CA 94404 Phone: (650) 573-1968 Fax: (650) 573-1969 Regulatory Contact: Hellen Professional Services Phone: (818) 709-5646

II. DEVICE NAME and CLASSIFICATION:

Proprietary Name:	BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test
Catalog Number:	850116
Common Name:	BioCheck Cardiac-1 Rapid Test
Classification Name:	Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System (862.1215)

111. INTENDED USE and ASSAY PRINCIPLE:

IV. SUBSTANTIAL EQUIVALENCE:

The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is a modification of the existing BioCheck Serum Troponin I Rapid Test (formerly, the VBL Serum Troponin I Test, K023505; currently manufactured by BioCheck, Inc., Foster City, CA 94404). The original rapid troponin I test was cleared for use on serum samples, and the new, reformulated device can be used to detect human cTnl in whole blood, plasma or serum specimens. The intended use of the product has not been altered significantly, only expanded to include the use of whole blood and plasma samples.

V. TEST PERFORMANCE:

1. Precision

PRECISION-BETWEEN RUNS AT FOUR DIFFERENT TESTING SITES SERUM . Samples
Four laboratories were provided with blind serum samples that had been spiked with purified complex cTnl *. Three serum samples containing 0. 1.5, and 3.0 ng/ml cTn1 were prepared. Five blind replicates of each sample were tested in each site for a total of 15 tests per site. All samples were also tested in manufacture's laboratory. The assay results demonstrated 100% agreement in between run proficiency and 100% agreement between sites using serum samples.
. PRECISION-BETWEEN RUNS AT FOUR DIFFERENT TESTING SITES - WHOLE BLOOD Samples
Between run precision was evaluated at four different sites. Four laboratories were provided with blind whole blood samples which were spiked with purified complex cTn1. Samples were prepared containing 0 ng, 1.5 ng and 3.0 ng/ml of cTnl. Five blind replicates of each sample were tested at each site for a total of 15 tests per site. All samples were also tested in the manufacturer's laboratory. The assay results demonstrate 100% agreement in between-run proficiency. and 100% agreement between sites using whole blood samples.

2. Recovery Study

Sample recovery was tested using serum samples and whole blood samples with the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test.

For the serum evaluation, normal human serum was supplemented with partially purfied human cTnl complex to yield cTnl concentrations of 0, 0.5, 1.0, 1.5 and 3.0 ng/ml. The whole blood samples were tested by using normal human whole blood specimens spiked with partially purified human cTnl complex to yield cTnl concentrations of 0, 0.5, 1.0, 1.5 and 3.0 ng/ml.

The spiked samples were tested in six replicates using the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test. The data showed 100% agreements between the expected and the observed results at each cTnl concentration for both serum and whole blood samples (results shown as # positive results/total # tested).

V. TEST PERFORMANCE:

3. Interference

The following potentially interfering substances do not appear to interfere with the determination of cTnl in the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test up to the levels indicated below. Identical results were observed in the serum-only test.

Analyte	Test Level	Analyte	Test Level
Biotin	200 ng/ml	Human muscle Troponin T	2.5 µg/ml
Bilirubin	20 mg/dl	Human muscle Troponin I	2.5 µg/ml
Hemoglobin	1200 mg/dl	Cholesterol	800 mg/dl
Rabbit skeletal muscle
Troponin C	2.5 µg/ml	Triglyceride	1250 mg/dl
Human cardiac Troponin T	2.5 µg/ml

In vitro testing of the following common-used drugs revealed no interference at the upper level of the therapeutic range in the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test. Identical results were observed in the serum-only test.

Analyte	Test Level	Analyte	Test Level
Acetaminophen	30 µg/ml	Digitonin	10 µg/ml
Acetylsalicylic acid	200 µg/ml	Digoxin	10 µg/ml
Adenine	10 µg/ml	Dopamine	10 µg/ml
Albumin (bovine)	50 mg/ml	Erythromycin	20 µg/ml
Allopurinol	20 µg/ml	Gentistic acid	10 µg/ml
Ambroxol	10 µg/ml	Isoproterenol	10 µg/ml
Ampicillin	20 µg/ml	Isosorbide dinitrate	50 µg/ml
Ascorbic acid	20 µg/ml	Nifedipine	200 µg/ml
Atenolol	10 µg/ml	Nystatin	10 µg/ml
Atropine	10 µg/ml	Oxazepam	10 µg/ml
Caffeine	20 µg/ml	Oxytetracycline	10 µg/ml
Captopril	10 µg/ml	Propranolol	10 µg/ml
Chloramphenicol	25 µg/ml	Theophylline	20 µg/ml
Cinnarizine	10 µg/ml	L-thyroxine	10 µg/ml
Cyclophosphamide	125 µg/ml	Urea	400 µg/ml
Cyclosporine	10 µg/ml	Uric acid	100 µg/ml

4. Clinical Comparison

CLINICAL CORRELATION STUDY .

A total of 245 patient serum samples were tested using the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test. Results were compared with a commercially available quantitative ELISA assay for cTnl as shown below:

| BioCheck Whole Blood /
Plasma / Serum cTnl
Rapid Test | BioCheck, Inc.
Troponin I ELISA Test | |
|-------------------------------------------------------------|-----------------------------------------|-------------|
| | ≥ 1.5 ng/ml |