BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

K041619 · Biocheck, Inc. · MMI · Dec 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041619
• Device Name: BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
• Applicant: Biocheck, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended 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).

Device Story

Colloidal gold/antibody conjugate-based lateral flow immunoassay; detects cardiac troponin I (cTnI) in human whole blood, plasma, or serum. Sample dispensed into well; red blood cells bound by immobilized anti-red blood cell reagents in sample pad; plasma migrates via capillary action. cTnI binds to gold-antibody conjugate; complex migrates to test region; reacts with three immobilized anti-cTnI monoclonal antibodies to form pink band at concentrations ≥ 1.5 ng/ml. Procedural control line confirms test validity. Used in clinical settings; operated by healthcare professionals. Provides qualitative visual result; aids clinicians in diagnosing acute myocardial infarction.

Clinical Evidence

Clinical correlation study of 245 patient serum samples compared to quantitative ELISA; sensitivity 97.3%, specificity 97.1%, accuracy 97.1%. Whole blood/plasma correlation study (n=68) showed 100% agreement. Confirmed MI patient study (n=24) showed 95.8% agreement with patient status; non-MI patient study (n=44) showed 100% agreement. Precision and recovery studies performed across four sites using spiked samples showed 100% agreement.

Technological Characteristics

Colloidal gold/antibody conjugate lateral flow immunoassay. Components: sample pad with immobilized anti-red blood cell reagents, membrane with three immobilized anti-cTnI monoclonal antibodies. Qualitative visual readout. Standalone test device. No external energy source required.

Indications for Use

Indicated for qualitative detection of cardiac troponin I in human whole blood, plasma, or serum to aid in the evaluation of acute myocardial infarction (AMI).

Regulatory Classification

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.

Predicate Devices

• BioCheck Serum Troponin I Rapid Test (K023505)

Submission Summary (Full Text)

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### 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: [phone] Fax: [phone] Regulatory Contact: Hellen Professional Services Phone: [phone]

#### 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:

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).

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.

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#### 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).

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#### 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<br>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 |

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#### 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 /<br>Plasma / Serum cTnl<br>Rapid Test | BioCheck, Inc.<br>Troponin I ELISA Test | |
|-------------------------------------------------------------|-----------------------------------------|-------------|
| | ≥ 1.5 ng/ml | < 1.5 ng/ml |
| + | 73 | 5 |
| - | 2 | 165 |
| Total | 75 | 170 |

Sensitivitv = 73 / 75 = 97.3% Specificity = 165 /170 = 97.1% Overali Accuracy = 238 /245 = 97.1%

- CORRELATION STUDY between WHOLE BLOOD and PLASMA Samples . Sixty-eight (68) patient whole blood samples were collected and plasma isolated. The paired samples were tested using the BioCheck Whole Blood/Plasma/Serum cToil Rapid Test. The agreement between the whole blood test and plasma test was 100% (68/68),
#### V. TEST PERFORMANCE:

- t CLINICAL STUDIES - CONFIRMED MI Patients: BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test and BioCheck ELISA Test Twenty-four (24) whole blood specimens from confirmed MI patients were tested with the BioCheck Whole Blood/Plasma/Serum cTn1 Rapid Test and BioCheck cTnJ ELISA..Test. Among these specimens, 23 were found to have positive test results and the agreement with the patient status was found to be 95.8% (23/24).
CLINICAL STUDIES - NON-MI Patients: BioCheck Whole Blood/Plasma/Serum cTn1 . Rapid Test and BioCheck ELISA Test Similarly, whole blood specimens from non-MI patients (n=44) were tested with the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test and the BioCheck cTnl ELISA Test. Negative results were obtained for both test protocols for all 44 speciments and 100% (44/44) agreement was achieved.

- CORRELATION of ASSAY RESULTS BETWEEN WHOLE BLOOD AND SERUM . SAMPLES
A pair of samples, one whole blood (WB) and one serum (S), were collected from each of 20 individuals. The whole blood and serum samples from each individual were spiked with the same amount of purified complex cThil. The samples of 17 individuals were prepared containing ≥ 1.5 ng/ml of cTnl while samples of 3 individuals containing < 1.5 ng/ml of cTnl. The agreement between the use of whole blood and serum was 100%.

CAT. NO. 850116PI

Revision Date: 09-01-04

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 17 2004

Biocheck, Inc. c/o Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325

Re: k041619

Trade/Device Name: BioCheck, Inc. Whole Blood/ Plasma/ Serum cTnl Rapid Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/ creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: November 8, 2004 Received: November 17, 2004

Dear Ms. Hellen:

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 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).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you wo ough finding of substantial equivalence of your device to a legally premained notificate 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 of quostions on the promie Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Device Name:

BioCheck, Inc. Whole Blood/Plasma/Serum cTnl Rapid Test

Indications for 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).

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

に

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Bensam
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K041619