CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592

K962426 · Chrono-Log Corp. · JOZ · Oct 22, 1996 · Hematology

Device Facts

• Record ID: K962426
• Device Name: CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
• Applicant: Chrono-Log Corp.
• Product Code: JOZ · Hematology
• Decision Date: Oct 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

Indications for Use

The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.

Device Story

Device measures platelet aggregation in whole blood samples via electrical impedance; utilizes electrode with two platinum alloy wires. Small voltage applied across wires; platelet monolayer forms; baseline established. Upon agonist addition, platelets aggregate on wires, altering impedance proportional to aggregation extent. Model 591 (single channel) and Model 592 (dual channel) display impedance changes on front panel; analog output connects to strip chart recorder for aggregation curve visualization. Used in clinical laboratory settings by trained personnel. Output assists clinicians in evaluating platelet function and aggregation dynamics.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrical impedance measurement; platinum alloy wire electrodes. Single (Model 591) or dual (Model 592) channel configuration. Analog output for strip chart recording. No software/firmware described.

Indications for Use

Indicated for the determination of platelet function in whole blood specimens for clinical assessment of platelet aggregation.

Regulatory Classification

Identification

An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

Predicate Devices

• Chrono-log Whole Blood Aggregometer (K830749)
• Centocor AggreStat (K954997)

Submission Summary (Full Text)

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K 962426

OCT 22 1996

510(k) Summary

Device: Chrono-log Whole Blood Aggregometer (WBA), Model 591/592

Date: June 16, 1996

Submitted by: Chrono-log Corp., 2 West Park Rd., Havertown, PA 19083

Contact: Nicholas J. Veriabo [phone]

Name of Device:

Trade/Proprietary Name - Chrono-log Whole Blood Aggregometer (WBA), Model 591/592

Common/Usual Name - Chrono-log Whole Blood Aggregometer

Classification Name - System, Automatic Platelet Aggregation

After examining the tests data included in this application, we have found the Chrono-log Whole Blood Aggregometer (WBA), Model 591/592 to be substantially equivalent to Chrono-log Whole Blood Aggregometer (K830749) and Centocor AggreStat (K954997).

Device Description:

The Chrono-log WBA, Model 591/592 uses electrical impedance to measure platelet aggregation in a whole blood sample. The Impedance is measured using an electrode with two platinum alloy wires. A small voltage is applied across these two wires. When the electrode is placed into a diluted whole blood specimen and a monolayer is formed around the two wires. In the absence of an agonist, the platelet build-up stabilizes and a baseline is established. When an agonist is added to the specimen, the platelets begin to aggregate and collect on the electrode wires causing a change in impedance. The change of impedance is directly proportional to the amount of Aggregation in the specimen. The change of impedance is displayed on a front panel readout. An analog output which, when connected to a strip chart recorder, provides an aggregation curve. Model 591 is a single channel version; Model 592 is the dual channel version.

Intended Use:

The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.