KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM

K955735 · Sigma Diagnostics, Inc. · JPA · Mar 11, 1996 · Hematology

Device Facts

• Record ID: K955735
• Device Name: KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Amelung KC 4 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 4 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; operated by laboratory personnel. Device measures clotting time; provides quantitative results for coagulation assays. Results assist clinicians in monitoring patient coagulation status and managing therapy. Benefits include standardized, reliable coagulation testing in clinical settings.

Clinical Evidence

Performance studies conducted at three physician office laboratories (n > 45 samples) and in-house (n > 100 samples). Compared KC 4 A against reference laboratory and predicate devices (Fibrometer, CA-5000). PT/APTT correlation coefficients ranged 0.927-0.991. Fibrinogen/Factor IX/Factor X correlation coefficients ranged 0.897-0.974. Precision studies showed CV < 9%.

Technological Characteristics

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

Indications for Use

Indicated for patients requiring coagulation testing, including PT, APTT, fibrinogen, and other clotting assays where fibrin formation is the endpoint. Used in physician office laboratories and clinical settings.

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 4 A Micro
Coagulation Analyzer
December 15, 1995

K.G. 5735

# ATTACHMENT 1

## Summary of Safety and Effectiveness

{1}

510(k) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
KC 4 A Micro
Coagulation Analyzer
December 15, 1995

# ATTACHMENT 1

## 510(k) Summary of Safety and Effectiveness

The Amelung KC 4 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 4 A.

In beta sites performance studies, three physician office laboratories (POL) analyzed more than 45 samples using the KC 4 A. Split samples from the same specimens were also analyzed using the KC 4 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 = 0.991 y = 0.981x + 0.492 |
| --- | --- |
| | APTT: r = 0.960 y = 1.066x + 0.379 |
| **Site #2:** | PT: r = 0.989 y = 1.019x - 0.248 |
| | APTT: r = 0.965 y = 1.029x + 1.021 |
| **Site #3:** | PT: r = 0.974 y = 1.012x + 0.326 |
| | APTT: r = 0.927 y = 0.786x + 9.470 |

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 4 A and the Fibrometer. The CA-5000 was used as the predicate device for Fibrinogen, Factor IX, and Factor X assays. The correlation coefficient and the regression equation were as follows:

| PT: | r = 0.988 | y = 1.051x - 0.241 |
| --- | --- | --- |
| APTT: | r = 0.896 | y = 1.235x + 0.873 |
| Fibrinogen: | r = 0.930 | y = 1.067x + 30.749 |
| Factor IX: | r = 0.897 | y = 0.958x - 3.403 |
| Factor X: | r = 0.974 | y = 1.010x - 0.166 |

Precision studies were performed in-house. The coefficient of variation (CV) for all studies was less than 9%.

These data clearly demonstrate that the performance of the KC 4 A Micro Coagulation Analyzer is substantially equivalent to the performance of the predicate device.