KC 1A COAGULATION ANALYZER/SET

K955724 · Sigma Diagnostics, Inc. · JPA · Mar 12, 1996 · Hematology

Device Facts

• Record ID: K955724
• Device Name: KC 1A COAGULATION ANALYZER/SET
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.

Device Story

Semi-automated mechanical clot detection system; determines PT, APTT, fibrinogen, and other clotting tests with fibrin formation endpoints. Used in physician office laboratories (POL) and clinical settings; operated by laboratory personnel. Device measures clotting time via mechanical detection; results used by clinicians to assess coagulation status and guide therapeutic decisions. Benefits include standardized, reliable coagulation monitoring.

Clinical Evidence

Performance studies conducted at three physician office laboratories (n > 45 samples) and in-house (n > 100 samples). Compared KC 1 A against reference laboratory results and predicate devices (Fibrometer, CA-5000). PT correlation (r) ranged 0.981-0.992; APTT correlation (r) ranged 0.867-0.935; Fibrinogen correlation (r) = 0.932. Precision studies showed CV < 6%.

Technological Characteristics

Semi-automated mechanical clot detection system. Benchtop form factor. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for patients requiring coagulation testing, specifically PT, APTT, and fibrinogen concentration determination, where fibrin formation is the endpoint.

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

• Fibrometer
• CA-5000

Submission Summary (Full Text)

{0}

510(k) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
KC 1 A Micro
Coagulation Analyzer
December 15, 1995

MAR 12 8:45

# ATTACHMENT 1

## Summary of Safety and Effectiveness

{1}

510(k) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
KC 1 A Micro
Coagulation Analyzer
December 15, 1995

# ATTACHMENT 1

## 510(k) Summary of Safety and Effectiveness

The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.

In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 1 A. Split samples from the same specimens were also analyzed using the KC 1 A at Sigma Diagnostics, the study’s reference laboratory. PT and APTT assays were performed at all sites. The correlation coefficient and the regression equation for these comparisons were as follows:

| Site #1: | PT: r = 0.981 y = 1.018x + 0.129
APTT: r = 0.935 y = 1.050x + 2.057 |
| --- | --- |
| Site #2: | PT: r = 0.992 y = 0.950x + 0.617
APTT: r = 0.922 y = 1.026x + 1.924 |
| Site #3: | PT: r = 0.981 y = 1.012x + 0.181
APTT: r = 0.929 y = 0.961x + 3.964 |

Precision studies were also performed at all sites. Results were within acceptable limits.

In in-house performance studies, PT and APTT were performed on more than one hundred samples using both the KC 1 A and the Fibrometer. The CA-5000 was used as the predicate device for the fibrinogen. The correlation coefficient and the regression equation were as follows:

| PT: | r = 0.987 | y = 1.046x - 0.280 |
| --- | --- | --- |
| APTT: | r = 0.867 | y = 1.263x - 1.647 |
| Fibrinogen: | r = 0.932 | y = 1.065x + 29.375 |

Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 6%.

These data clearly demonstrate that the performance of the KC 1 A Micro Coagulation Analyzer is substantially equivalent to the performance of the predicate device.

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