ARCHITECT STAT TROPONIN-I IMMUNOASSAY

K041192 · Fisher Diagnostics · MMI · Aug 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041192
• Device Name: ARCHITECT STAT TROPONIN-I IMMUNOASSAY
• Applicant: Fisher Diagnostics
• Product Code: MMI · Clinical Chemistry
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

Device Story

The ARCHITECT STAT Troponin-I assay is a two-step Chemiluminescent Microparticle Immunoassay (CMIA) performed on the ARCHITECT i System. The device processes human serum or plasma samples. In the first step, the sample is combined with assay diluent and anti-troponin-I antibody-coated paramagnetic microparticles. After incubation and washing, an anti-troponin-I acridinium-labeled conjugate is added. Following a second incubation and wash, pre-trigger and trigger solutions are added to initiate a chemiluminescent reaction. The system measures the resulting relative light units (RLUs), which are directly proportional to the concentration of troponin-I in the sample. The concentration is determined relative to a standard curve established with known calibrators. The assay is used in clinical laboratory settings to assist healthcare providers in diagnosing myocardial infarction.

Clinical Evidence

Clinical performance was evaluated by comparing the ARCHITECT STAT Troponin-I assay to the predicate Access® AccuTnl assay. The study demonstrated substantial equivalence in sensitivity and specificity using an optimal AMI cut-off of 0.30 ng/mL. A method comparison between the two systems confirmed equivalent performance. Sample stability was validated for Lithium Heparin and Serum Separator collection tubes, showing no systematic gain or loss of troponin-I detectability under evaluated storage conditions.

Technological Characteristics

CMIA technology; uses paramagnetic microparticles coated with anti-troponin-I antibodies; acridinium-labeled conjugate; TRIS buffer; Proclin® 300 preservative; chemiluminescent detection measured in relative light units (RLUs); automated processing on ARCHITECT i System.

Indications for Use

Indicated for the quantitative determination of cardiac troponin-I in human serum and plasma to assist in the diagnosis of myocardial infarction (MI).

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

• Access® AccuTnl Assay (K021814)

Submission Summary (Full Text)

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ARCHITECT® STAT Troponin- I Assay May 5, 2004

sher Diagnostics A Fisher Scientific Company

## 6.3 Summary of Safety and Effectiveness

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

AUG 1 2 2004

## Applicant Name:

Josefina Infantas, MSM Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike P.O. Box 307 Middletown, VA 22645 Phone: [phone] Fax: [phone]

### Establishment Registration Number: 1181121

### Identification of Device:

Device Name: ARCHITECT® STAT Troponin-I immunoassay Proprietary/Trade Name: ARCHITECT® STAT Troponin-I immunoassay Common Name: Troponin-I test system Device Classification: Class II Governing Regulation: 21 CFR 862.1215 FDA Panel: Clinical Chemistry (75) Product Code: MMI

### Identification of Predicate Device:

Access® AccuTnl Assay (K021814)

### Intended Use of the Device:

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).

# Description of the Device:

The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read

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A Fisher Scientific Company 8365 Valley Pike P.O. Box 307 Middletown, VA 22645-0307

540-869-3200 Tel: Fax: [phone]

fishersci.com

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### ARCHITECT® STAT Troponin- I Assay May 5, 2004

relative to a standard curve established with calibrators of known troponin-l concentration.

#### Comparison of Technological Characteristics:

The ARCHITECT® STAT Troponin-I and the ACCESS® AccuTnl assays use a The ANOTH EST of CMA trioperimmunoassay (CMIA) method for the quantitative determination of cardiac troponin-I in human serum and plasma. Values obtained are used to assist in the diagnosis of myocardial infarction. Proclin® 300 is a presenvative used all reagent components (microparticles, diluent and conjugate) of the ACCESS ascu an roagent computhe diluent and conjugate of the ARCHITECT STAT Troponin-i contain Proclin® 300 as a preservative. The ARCHITECT STAT Troponin-1 microparticles contain an antimicrobial agent as a preservative. Both assays have microparticles contain an antimorsenal anti-troponin-l in TRIS buffer. The conjugates both contain mouse monoclonal anti-troponin-l.

#### Summary of Non-clinical Performance:

The ARCHITECT® STAT Troponin-I assay is substantially equivalent to the ACCESS® AccuTnl assay in terms of precison, linearity, interferences, and stability as demonstrated in non-clinical performance data in this 510(k) submission.

#### Summary of Clinical Performance:

The ARCHITECT STAT Troponin-I assay demonstrated sensitivity and specificity that is substantially equivalent to the ACCESS AccuTnl assay, using the optimal AMI "cut-off" of 0.30 ng/mL as indicated by clinical data in this 510(k) submission. The sample stability study evaluated ARCHITECT STAT Troponin-I assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison was also conducted with the ARCHITECT STAT Troponin-I and ACCESS AccuTnl assays and as a result, the two systems demonstrated substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 2 2004

Ms. Josefina Infantas, MSM Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike PO Box 307 Middletown, VA 22645

k041192 Re:

Ro Froz ARCHITECT STAT Troponin- I Calibrators Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT Dated: August 5, 2004 Received: August 5, 2004

Dear Ms. Infantas:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have tevice would four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to stgms) the enactment date of the Medical Device Amendments, or to conninered pror to May 2017, in accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, manns of the Act include requirements for annual registration, listing of general controls proficies gractice, 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 your device is etablifical controls. Existing major regulations affecting your device It may be subject to such additions controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Title = nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advilsed that I Driver device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I cacrates and regaranents, including, but not limited to: registration and listing (21

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin mixing of substantial equivalence of your device to a legally premaired notincation: The PDF intembers of 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion and Safety at [phone]. Also, please note the In I the Diaglessed Dorlov by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ovain other general messans 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,

Jain M. Cooper MS, DVM.

Jean M. Cooper, MS, D.V.M. 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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#### 6.1 Indications for Use

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle AHCHITECT UTAT Troponin' Hopenin' House Mation of cardiac troponin-l Infridnoussay (Owling for the quema on the ARCHITECT i System with STAT (CTTI) in numan oram and I values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT Troponin-I Calibrators are for calibration of the The ANOHITEOT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: ARCHITECT® STAT Troponin-I Immunoassay

Over-The-Counter Use Use Prescription × (21 CFR 807 Subpart C) -- AND/OR (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson
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510(k) K041192