AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

K021162 · Sigma Diagnostics, Inc. · JPA · Aug 30, 2002 · Hematology

Device Facts

• Record ID: K021162
• Device Name: AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Device Story

Automated random access multipurpose coagulation analyzer; performs clot-based tests (PT, APTT, fibrinogen, factor assays), chromogenic assays (AT III), and microparticle agglutination assays (d-dimer). Utilizes mechanical (ball method) or photo-optical principles for fibrin formation detection. Operated by laboratory personnel in clinical settings. Provides quantitative results for coagulation parameters; assists clinicians in diagnosing and monitoring coagulation disorders. Benefits include standardized, automated testing with high precision and correlation to established analyzer performance.

Clinical Evidence

Bench testing only. Comparison studies between AMAX Destiny™ and AMAX 190™ performed for multiple assays (PT, APTT, Factor IX, Factor X, Fibrinogen, Thrombin time, AT III, D-dimer). Regression statistics (r-values ranging from 0.913 to 0.995) and precision studies (within-run and total CVs) provided to demonstrate performance equivalence.

Technological Characteristics

Automated random access analyzer; dual detection technology (mechanical ball method and photo-optical); performs clot-based, chromogenic, and agglutination assays. System includes instrument, reagents, and controls. Class II device (21 CFR 864.5425).

Indications for Use

Indicated for in vitro coagulation studies and coagulation factor assays in a clinical laboratory setting. Intended for prescription use.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• AMAX 190™ Coagulation Analyzer

Submission Summary (Full Text)

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## 510(k) NOTIFICATION

Sigma Diagnostics Inc. March 13, 2002

| | 510(k) Summary of Safety and Effectiveness | K021162 |
|------------------------|-----------------------------------------------------------------------------------|--------------|
| Submitted by: | Sigma Diagnostics<br>545 South Ewing Av<br>St. Louis, MO 63103 | AUG 3 0 2002 |
| Contact Person: | William R. Gilbert, Ph.D.<br>Manager, Scientific Affairs<br>314-286-6693 | |
| Preparation Date: | July 12, 2002 | |
| Device Name: | AMAX Destiny™ Coagulation Analyzer | |
| Device Classification: | JPA, Multipurpose system for in vitro coagulation studies, Class II<br>(864 5425) | |

The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.

In comparison studies of assays between the AMAX Destiny™ Coagulation Analyzer and the AMAX 190™ Coagulation Analyzer, the following regression statistics were obtained:

| PT (optical) | r = 0.993 | y = 1.223x - 1.5 |
|----------------------------|-----------|-------------------|
| PT (mechanical) | r = 0.994 | y = 1.180x - 2.5 |
| APTT (optical) | r = 0.913 | y = 1.191x - 1.2 |
| APTT (mechanical) | r = 0.923 | y = 1.112x - 2.3 |
| Factor IX (optical) | r = 0.977 | y = 0.928x + 3.8 |
| Factor IX (mechanical) | r = 0.964 | y = 0.880x + 3.9 |
| Factor X (optical) | r = 0.982 | y = 0.935x + 3.3 |
| Factor X (mechanical) | r = 0.972 | y = 0.957x + 2.5 |
| Fibrinogen (optical) | r = 0.978 | y = 0.974x + 27.3 |
| Fibrinogen (mechanical) | r = 0.968 | y = 1.069x - 14.5 |
| Thrombin time (mechanical) | r = 0.990 | y = 0.965x + 1.5 |
| AT III (chromogenic) | r = 0.934 | y = 1.070x - 8.8 |
| D-dimer (agglutination) | r = 0.995 | y = 1.121x - 57.0 |

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Sigma Diagnostics Inc. March 13, 2002

The following coefficients of variation were obtained from precision studies:

| | Within Run | Total |
|----------------------------|------------|--------|
| PT (optical) | <2.0% | <3.8% |
| PT (mechanical) | <1.2% | <3.8% |
| APTT (optical) | <1.4% | <2.1% |
| APTT (mechanical) | <1.3% | <2.3% |
| Factor IX (optical) | <4.4% | <7.2% |
| Factor IX (mechanical) | <4.3% | <8.4% |
| Factor X (optical) | <3.0% | <5.9% |
| Factor X (mechanical) | <4.7% | <8.8% |
| Fibrinogen (optical) | <2.3% | <4.7% |
| Fibrinogen (mechanical) | <4.1% | <5.4% |
| Thrombin time (mechanical) | <2.0% | <3.6% |
| AT III (chromogenic) | <2.9% | <5.2% |
| D-dimer (agglutination) | <13.3% | <33.0% |

The safety and effectiveness of the AMAX Destiny™ Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics 545 South Ewing Avenue St. Louis, Missouri 63103

AUG 3 0 2002

Re: k021162

> Trade/Device Name: AMAX Destiny™ Coagulation Analyzer Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: July 12, 2002 Received: July 16, 2002

Dear Dr. Gilbert:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 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 premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

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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## 510(k) Number (if known): __ KOAII (62

Device Name: AMAX Destiny™ Coagulation Analyzer

## Indications For Use:

The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Josephine. Bantler.

(Divisibri Sidh-Off) Division of Clinical Laboratory Devices 510(k) Number -

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________