INSTANT-VIEW TROPONIN I TEST

K042227 · Alfa Scientific Designs, Inc. · MMI · Nov 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042227
• Device Name: INSTANT-VIEW TROPONIN I TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.

Device Story

Lateral flow chromatographic immunoassay for qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum. Device consists of test strip with conjugate pad (colloidal gold-labeled anti-cTnI antibodies) and nitrocellulose membrane (test line with anti-cTnI antibodies; control line with goat anti-mouse IgG). Used in emergency rooms, point-of-care, and hospital settings by healthcare professionals. Sample application triggers capillary flow; presence of cTnI at ≥1.5 ng/ml results in visible test line. Control line confirms adequate sample volume and proper flow. Results provide qualitative aid in myocardial infarction diagnosis; clinical judgment required for final diagnosis. Available in cassette or dip strip formats.

Clinical Evidence

Performance evaluated using 300 clinically confirmed serum specimens (150 positive, 150 negative). Sensitivity reported at 99.3% (149/150) and specificity at 96.0% (144/150), with 97.7% overall accuracy. Reproducibility tested at four sites (three physician offices, one medical lab) using 80 samples at four concentration levels (0, 0.1, 1.5, 10 ng/ml), showing >98.8% agreement. Interference and cross-reactivity studies confirmed no interference from common drugs/analytes (10 ug/ml) or cross-reactivity with other troponins, bilirubin, or cholesterol.

Technological Characteristics

One-step lateral flow chromatographic immunoassay. Components: nitrocellulose membrane, conjugate pad with colloidal gold-labeled anti-cTnI antibodies. Test line coated with anti-cTnI antibodies; control line coated with goat anti-mouse IgG. Formats: cassette (dip strip in plastic housing) or dip strip. Qualitative detection at 1.5 ng/ml cutoff. Standalone device; no energy source required. Manual operation.

Indications for Use

Indicated for rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum (cutoff 1.5 ng/ml) as an aid in diagnosing myocardial infarction in emergency, point-of-care, and hospital settings. Not for monitoring temporal changes in cTnI levels; serial testing or quantitative methods recommended for such purposes.

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

• VBL Serum Troponin I Test by Vancouver Biotech LTD. (K023505)

Submission Summary (Full Text)

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K042227

| NOV 19 2004 | | 510(k) Summary of<br>Safety and Effectiveness as Required by 21 CFR 807.92 |
|------------------------------|----------------------------|------------------------------------------------------------------------------------------------|
| Manufacture and<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
| | Address: | 12330 Stowe Drive<br>Poway, CA 92064<br>Telephone: [phone] x 308<br>Fax: [phone] |
| | Contact Person:<br>E-mail: | Naishu Wang, MD, Ph.D.<br>[e-mail] |
| | Device Name | Trade Name: |
| | | Common Name: |
| Classification: | | |

| | Creatine phosphokinase/creatine kinase or isoenzymes<br>test system |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary<br>Preparation | August 12, 2004 |
| Predicate Device | VBL Serum Troponin I Test by Vancouver Biotech LTD.<br>K023505 |
| Device Description | A one-step lateral flow chromatographic immunoassay. The test<br>strip in the device consists of 1) a burgundy-colored conjugate pad<br>containing colloidal gold coupled with anti- Troponin I antibodies,<br>and 2) nitrocellulose membrane containing a test line (T line) and a<br>control line (C line). The T line is coated with anti- Troponin I<br>antibodies, and the C line is coated with goat anti-mouse IgG<br>antibodies. |
| Summary of the<br>Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are qualitative tests.<br>• Both are in-vitro diagnostic devices.<br>• Both have a built-in quality control feature, C line, to indicate that<br>an adequate volume of sample is applied and the liquid flow<br>occurred properly |

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| Intended Use | The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid<br>qualitative detection of cardiac troponin I (cTnI) in human whole<br>blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in<br>the diagnosis of myocardial infarction in emergency room, point-of-<br>care, and hospital setting. |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity and<br>Specificity Study | The sensitivity and specificity of the device was evaluated against<br>300 clinically confirmed serum specimens, 150 positive and 150<br>negative. The results demonstrated that the INSTANT-VIEW® Troponin<br>I Test have a sensitivity of 99.3% (149/150) and a specificity of<br>96.0% (144/150). The overall accuracy of this device is 97.7%<br>(293/300). |
| Reproducibility<br>study | Reproducibility studies were performed on 80 samples with the<br>concentration of human cardiac troponin I evenly distributed at four<br>different levels: 0, 0.1, 1.5, 10 ng/ml. Each sample was tested at<br>three physician's office laboratories (POLs) and one medical<br>analysis laboratory. The agreements at the four sites were over<br>98.8%. |
| Interference and<br>Cross-reactivity<br>Study | No cross-reaction was observed with the closely related substances,<br>such as troponins other than human cardiac troponin bilirubin, and<br>cholesterols.<br>No interference was observed with endogenous substances including<br>commonly used drugs or analytes at a concentration of 10 ug/ml. |
| Formats of the<br>Device | The proposed device has two formats: Serum Test and Whole<br>Blood/Serum Test. The Serum Test has two sub-formats: Cassette<br>and Dip Strip. The Whole Blood/Serum Test only has the cassette<br>format. A cassette is a device that assembles a dip-strip in a plastic<br>housing. The studies demonstrate all the formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross<br>reactivity, and interference studies demonstrate that the INSTANT-<br>VIEW Troponin I Test is substantially equivalent to the predicate<br>device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 9 2004

Naishu Wang, MD., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064

k042227 Re: Trade/Device Name: INSTANT-VIEW® Troponin I Serum Test (Cassette) INSTANT-VIEW® Troponin I Serum Test (Dip Strip) INSTANT-VIEW® Troponin I Whole Blood/Serum Test (Cassette) Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: October 28, 2004 Received: November 4, 2004

Dear Dr. Wang:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 Vitro Diagnostic Device 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,

Cornelius B. Loker

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

510(k) Number (if known): K04 2227

Device Name: INSTANT-VIEW® Troponin I Serum Test (Cassette) INSTANT-VIEW® Troponin I Serum Test (Dip Strip) INSTANT-VIEW® Troponin I Whole Blood/Serum Test (Cassette)

Indications For Use:

The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.

The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.

Prescription Use_ ✓ (Pert 21 CFR 801 Subpart D)

AND/OR

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

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

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

Carol Beman
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042227

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