Who is the manufacturer of KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)?

Sigma Diagnostics, Inc. filed the 510(k) submission for KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) (K960875).

What is the FDA product code for KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)?

JPA. It is classified under 21 CFR 864.5425 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)?

TOA Medical Electronics CA-5000; BBL Fibrometer.

Who can help prepare an FDA 510(k) submission like KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)

K960875 · Sigma Diagnostics, Inc. · JPA · Sep 10, 1996 · Hematology

Device Facts

Record ID	K960875
Device Name	KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
Applicant	Sigma Diagnostics, Inc.
Product Code	JPA · Hematology
Decision Date	Sep 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.5425
Device Class	Class 2

Intended Use

The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

Device Story

Automated random access coagulation analyzer; utilizes mechanical ball method to detect fibrin formation; performs PT, APTT, fibrinogen, and factor assays; used in clinical laboratory settings by trained personnel; provides quantitative clotting test results; assists clinicians in assessing patient coagulation status and managing anticoagulant therapy.

Clinical Evidence

Bench testing only. Comparison studies performed against TOA Medical Electronics CA-5000 and BBL Fibrometer. PT, APTT, Fibrinogen, Factor IX, and Factor X assays evaluated. Regression analysis showed high correlation (r=0.915 to 0.980). Precision studies demonstrated coefficient of variation <5% for PT/APTT, <6% for fibrinogen, and <10% for factor assays.

Technological Characteristics

Automated mechanical coagulation analyzer; utilizes 'ball method' for fibrin detection; random access architecture; designed for clinical laboratory environment.

Indications for Use

Indicated for clinical laboratory use for the detection of fibrin formation to perform clot-based coagulation assays including PT, APTT, fibrinogen, and factor assays.

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

TOA Medical Electronics CA-5000
BBL Fibrometer

Related Devices

K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM · Sigma Diagnostics, Inc. · Mar 13, 1996
K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED · Sigma Diagnostics, Inc. · Aug 30, 2002
K955735 — KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM · Sigma Diagnostics, Inc. · Mar 11, 1996
K970431 — BEHRING COAGULATION SYSTEM · Behring Diagnostics, Inc. · May 5, 1997
K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER · Medical Laboratory Automation Systems, Inc. · Sep 10, 1996

Submission Summary (Full Text)

{0} SEP 10 1996 K960875 510(k) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 KC 40 Micro Coagulation Analyzer February 27, 1996 # ATTACHMENT 1 ## 510(k) Summary of Safety and Effectiveness The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In comparison studies between the KC 40 and the TOA Medical Electronics CA-5000, the following regression statistics were obtained: | PT | r = 0.980 | y = 1.123x + 0.616 | | --- | --- | --- | | APTT | r = 0.936 | y = 1.101x + 4.570 | | Fibrinogen | r = 0.931 | y = 1.163x - 29.927 | | Factor IX | r = 0.944 | y = 0.964x + 7.937 | | Factor X | r = 0.970 | y = 1.040x - 1.884 | In comparison studies between the KC 40 and the BBL Fibrometer, the following regression statistics were obtained: | PT | r = 0.980 | y = 1.009x + 0.701 | | --- | --- | --- | | APTT | r = 0.915 | y = 1.244x - 0.778 | The coefficient of variation for precision studies was less than 5% for the PT and APTT assays, less than 6% for the fibrinogen assay, and less than 10% for the factor assays. The safety and effectiveness of the KC 40 Micro Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices.