Who is the manufacturer of ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

Medical Laboratory Automation Systems, Inc. filed the 510(k) submission for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (K962664).

What is the FDA product code for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

GKP. It is classified under 21 CFR 864.5400 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

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

Who can help prepare an FDA 510(k) submission like ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

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.

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER

Q: What are the predicate devices for ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER?

ELECTRA 1600C™ Automatic Coagulation Timer (K931206).

K962664 · Medical Laboratory Automation Systems, Inc. · GKP · Sep 10, 1996 · Hematology

Device Facts

Record ID	K962664
Device Name	ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
Applicant	Medical Laboratory Automation Systems, Inc.
Product Code	GKP · Hematology
Decision Date	Sep 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.5400
Device Class	Class 2

Intended Use

The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III.

Device Story

Automated coagulation analyzer; performs coagulation and chromogenic assays (PT, APTT, factor assays, fibrinogen, thrombin time, Antithrombin III). Input: patient blood samples in closed tubes. Operation: photometric analysis; automated sampling mechanism allows closed-tube sampling to reduce biohazard exposure. Output: quantitative coagulation/chromogenic test results. Used in clinical laboratories by trained personnel. Results assist clinicians in assessing patient coagulation status.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological comparison to predicate device.

Technological Characteristics

Automated coagulation timer and photometric analyzer. Features closed-tube sampling mechanism. System technology identical to predicate ELECTRA 1600C.

Indications for Use

Indicated for in vitro diagnostic coagulation and chromogenic testing, including PT, APTT, factor assays, fibrinogen, thrombin time, and Antithrombin III, in clinical laboratory settings.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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

ELECTRA 1600C™ Automatic Coagulation Timer (K931206)

Related Devices

K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM · Sigma Diagnostics, Inc. · Mar 13, 1996
K151259 — Sysmex Automated Blood Coagulation Analyzer CS-2100i · Siemens Healthcare Diagnostics Products GmbH · Jan 26, 2016
K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) · Sigma Diagnostics, Inc. · Sep 10, 1996
K970431 — BEHRING COAGULATION SYSTEM · Behring Diagnostics, Inc. · May 5, 1997
K972260 — CS-400 COAGULATION ANALYZER SYSTEM (A1208) · Sigma Diagnostics, Inc. · Oct 20, 1997

Submission Summary (Full Text)

{0} MLA K962664 # 510(k) Summary (21 CFR 807.92) SEP 10 1996 ELECTRA 1800C Automatic Coagulation Analyzer - **Submitter:** Medical Laboratory Automation, Inc. 270 Marble Avenue Pleasantville, New York 10570 - Tel. No.: (914) 747-3020 - Fax No.: (914) 747-0498 - Contact: JoAnn H. Lopez, Official Correspondent - Date Prepared: July 3, 1996 - **Device:** ELECTRA 1800C Automatic Coagulation Analyzer - Common Name: Automated Coagulation Instrument - Classification Name: Coagulation Instrument (as per 21 CFR 864.5400) - **Predicate Device:** ELECTRA 1600C™ Automatic Coagulation Timer (K931206) - **Device Description:** A detailed description of the device, including an explanation of how it functions and the basic scientific concepts, are described in the ELECTRA 1800C Operator’s Manual, Chapter 1 - Getting Started. - **Intended Use:** The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III. - **Device Comparison:** The proposed product, ELECTRA 1800C, is essentially equivalent in design to the ELECTRA 1600C™ Automatic Coagulation Analyzer. Basic system technology remains unchanged. The sample mechanism has been modified to allow for closed tube sampling. This modification has been included to limit operator exposure to bloodborne pathogens by eliminating standard practices such as removing tube stoppers for instrument sampling.