ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

K974839 · First Medical, Inc. · MMI · Feb 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974839
• Device Name: ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
• Applicant: First Medical, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.

Device Story

Alpha Dx System is a benchtop, fully integrated fluorescence immunoassay analyzer used with specific cardiac panel test kits. It accepts whole blood or serum samples to measure myoglobin, CK, CK-MB, and TnI. The system utilizes immunofluorometric procedures and fluorometric detection to provide quantitative results. Designed for use in central labs, STAT labs, emergency departments, coronary care units, and chest pain centers by healthcare professionals. It features factory calibration, built-in bilevel quality controls, and closed-tube sampling. The output provides rapid, laboratory-quality diagnostic data to clinicians to assist in the diagnosis of acute myocardial infarction (AMI), facilitating faster clinical decision-making in acute care settings.

Clinical Evidence

Clinical evaluation included testing 410 chest pain patients and 134 healthy individuals. Correlation studies between Alpha Dx and predicate methods (Stratus, Vitros, Access) showed high concordance (r=0.88 to 0.99). Clinical sensitivity for TnI was 93% (95% CI) and specificity was 94% (95% CI). Concordance between Alpha Dx TnI and Stratus CK-MB was 92%, with no statistically significant difference in diagnostic performance per McNemar's test.

Technological Characteristics

Benchtop fluorescence immunoassay analyzer. Uses immunofluorometric procedure with monoclonal and polyclonal antibodies. Employs fluorometric detection. Features factory calibration, built-in bilevel quality controls, and closed-tube sampling. Designed for point-of-care and laboratory environments.

Indications for Use

Indicated for the rapid, quantitative, and simultaneous measurement of myoglobin, CK, CK-MB, and TnI in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI) in patients presenting with chest pain.

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

• Dade Stratus Myoglobin Fluorometric Enzyme Immunoassay
• Johnson & Johnson Vitros CK Slide
• Dade Stratus CK-MB Fluorometric Enzyme Immunoassay
• Dade Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay
• Beckman Access Troponin I Immunoassay System
• Dade Stratus II Fluorometric Immunoassay System

Submission Summary (Full Text)

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### MEDICAL, INC. FIRST

## X 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

- Alpha Dx System
- A. Name and Address of Submitter
- . Company Name and Address:
- Telephone: ●
- FAX: .

Contact Person: ●

- . Date 510(k) summary was prepared:
- Device Names B.
- 1. Trade Names

The Alpha Dx System consists of:

- The Alpha Dx Analyzer, and .
- The Alpha Dx Myo/CK/CK-MB/TnI Cardiac Panel Test Kit, or .
- The Alpha Dx CK/CK-MB Panel Test Kit, or .
- The Alpha Dx Myo/TnI Panel Test Kit .
- Common Names 2.
- a. Alpha Dx Analyzer

Fully integrated benchtop analyzer capable of performing in vitro diagnostic measurement of a panel of tests.

- b. Alpha Dx Panel Test Kits
Rapid, quantitative and simultaneous measurement of myoglobin (Myo), creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI).

- 3. Classification Names
- a. Alpha Dx Analyzer

Fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of a panel of tests (Clinical Chemistry Panel Classification Device List).

- First Medical, Inc. 530 Logue Avenue Mountain View, CA 94043 [phone] [phone] Van N. Johnson December 23, 1997

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- b. Alpha Dx Panel Test Kits
Fluorescence Immunoassays for myoglobin, CK, CK-MB and TnI (Clinical Chemistry Panel and Immunology Classification Device List).

- C. Legally Marketed Devices
- 1. Panel Test Kits
- Dade Stratus Myoglobin Fluorometric Enzyme Immunoassay .
- Johnson & Johnson Vitros CK Slide .
- Dade Stratus CK-MB Fluorometric Enzyme Immunoassay ●
- Dade Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay ●
- . Beckman Access Troponin I Immunoassay System
- 2. Analyzer
- Dade Stratus II Fluorometric Immunoassay System ●
- D. Device Description

The Alpha Dx Cardiac Panel Test Kits, when used with the Alpha Dx Analyzer, are fluorescence immunoassays for the rapid measurement of myoglobin, CK, CK-MB and TnI in human whole blood or serum.

- E. Intended Use
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.

- F. Comparison of Methodology with Predicate Devices
The Alpha Dx Cardiac Panel Test Kit, when used with the Alpha Dx Analyzer, provides quantitative determinations of human myoglobin, CK, CK-MB and TnI in whole blood or serum. The current Stratus Myoglobin, CK-MB and Troponin I Fluorometric Enzyme Immunoassays when used with the Stratus II Fluorometric System Analyzer, the Vitros CK Slides when used with the Vitros 700 and the Access Troponin I Assay when used with the Access Immunoassay System are examples of other devices currently marketed for the same uses.

The Alpha Dx Cardiac Panel Test Kits are two-site fluorescence immunoassays. The current Stratus Myoglobin, CK-MB and Cardiac Troponin I Fluorometric Enzyme Immunoassays and the Stratus II Fluorometric Immunoassay Analyzer are examples of currently available products that employ the immunofluorometric procedure and fluorometric detection.

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Monoclonal and polyclonal antibodies are used in the Alpha Dx Cardiac Panel Test Kits. The use of monoclonal and polyclonal antibodies for immunoassay procedures has been clearly demonstrated in other currently commercially available assays and in numerous scientific reports.

- G. Summary of Analytical Data
- 1. Dilution Recoveries

The mean recoveries by diluting serum samples with high myoglobin, CK, CK-MB or TnI are as follows:

| Analyte | VIVO | AV | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>AV 120<br>JA-MD | 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTRACTORIAL COLLEGICAL COLLEGION CONSULTION OF<br>. Mean % Recoveries<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>C | AND LIES GENER<br>1<br>A SECT ANNUAL<br>------------------------------------------------------------------------------------------------------------------------------------------------ | 103<br>Carmer Research and Concell a co | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------------------------------------------------------------------<br>A CONSULTION COLLEGION OF COLLEGION |

Table 43 Dilution Recoveries

- Analytical Sensitivity 2.
The analytical sensitivity for the Alpha Dx myoglobin, CK, CK-MB and TnI assays are 1.1 ng/mL, 1.8 ng/mL, 0.04 ng/mL, 0.017 ng/mL, respectively.

- 3. Precision
Median %CV of the assays are as follows:

| %CV | Myo | CK | CK-MB | Tnl |
|---------------------|-----|-----|-------|-----|
| Whole Blood Samples | 3.9 | 5.3 | 3.9 | 7.3 |
| Serum Samples | 4.0 | 7.0 | 2.7 | 2.4 |

Table 44 Precision

- H. Summary of Clinical Data
- 1. Correlation Between Paired Whole Blood and Serum Samples Tested with the Alpha Dx System

Paired whole blood and serum samples from serial draws of 72 chest pain patients and 24 healthy individuals were tested. Linear regression analyses, after exclusion of samples with levels outside the reportable ranges of the test methods, are as follows:

| Method | Myo | CK | CK-MB | Tnl |
|-----------|------|------|-------|------|
| N | 322 | 309 | 294 | 73 |
| Slope | 1.05 | 1.04 | 1.07 | 0.90 |
| Intercept | -3 | 5 | -0.1 | 0.08 |
| r | 0.99 | 0.99 | 1.00 | 0.99 |

Table 45 Correlation Between Whole Blood and Serum

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- Correlations Between Whole Blood Samples Assayed with the Alpha Dx System and 2. Paired Serum Samples Assayed with the Predicate Methods
The relation between myoglobin, CK, CK-MB and TnI measurements with the Alpha Dx System and the predicate devices was determined in serial samples from 410 chest pain patients and 134 healthy individuals, after exclusion of samples with levels outside the reportable range of the test methods. Results of the regression analyses are as follows:

| | Myo | CK | CK-MB | TnI | TnI |
|-------------------|---------|--------|---------|---------|--------|
| Predicate | Stratus | Vitros | Stratus | Stratus | Access |
| N | 955 | 923 | 676 | 226 | 244 |
| Slope | 0.81 | 0.77 | 1.07 | 0.18 | 1.44 |
| Intercept (ng/mL) | -2 | -1 | 1.1 | 0.56 | 0.96 |
| r | 0.98 | 0.97 | 0.97 | 0.93 | 0.88 |

Table 46 Correlation Between Alpha Dx System and Predicate Methods

- 3. Clinical Sensitivity and Specificity of the Alpha Dx TnI, Stratus TnI, Access TnI and Stratus CK-MB Assays
The clinical cutoffs, sensitivity and specificity for the Alpha Dx TnI, Stratus TnI, Access TnI and the Stratus CK-MB are as follows:

| Method | Cutoff Value<br>(ng/mL) | Sensitivity<br>(95% Cl) | Specificity<br>(95% Cl) |
|---------------|-------------------------|-------------------------|-------------------------|
| Alpha Dx Tnl | 0.40 | 93 ± 6 | 94 ± 3 |
| Stratus Tnl | 1.50 | 93 ± 6 | 93 ± 3 |
| Access Tnl | 0.15 | 92± 6 | 88 ± 4 |
| Stratus CK-MB | 7.0 | 89± 7 | 90 ± 4 |

Table 47 Tnl and CK-MB Sensitivity and Specificity Comparison

Sensitivity and specificity for the Alpha Dx TnI and Stratus CK-MB are comparable within the 95% confidence intervals of the two methods. The Alpha Dx TnI assay results were 92% concordant versus the Stratus CK-MB results in 362 subjects tested with both devices. McNemar's test indicates no statistically significant difference between the two assays in diagnostic performance.

- Conclusion I.
The Alpha Dx Cardiac Test Discs are used with the Alpha Dx Analyzer for the rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The data shows that the Alpha Dx Cardiac Test Discs are substantially equivalent to other tests currently in commercial distribution for the purpose of analyzing unknown concentrations of myoglobin, CK, CK-MB and TnI.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### 1 1338 FR

Van N. Johnson . Vice President, Clinical and Regulatory Affairs First Medical, Inc. 530 Logue Avenue Mountain View, California 94043

Re : K974839 Alpha DX System Requlatory Class: I, II Product Code: MMI,JHX, DDR, CGX, KHO December 23, 1997 Dated: Received: December 24, I997

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set """" forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as The FDA described in your 510 (k) premarket notification. 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ / of _** /

K97483 510(k) Number (if known):_

Device Name:

Indications For Use:

Statement of Indication for Use

The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qyruic
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number. 4974839
Over-The-Counter Use

Prescription Use_ 2 (Per 21 CFR 801.109) OR

(Optional Format 1-2-96)