← Product Code [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ) · K962426

# CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 (K962426)

_Chrono-Log Corp. · JOZ · Oct 22, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K962426

## Device Facts

- **Applicant:** Chrono-Log Corp.
- **Product Code:** [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ.md)
- **Decision Date:** Oct 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5700
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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.

## Regulatory 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](/device/K830749.md))
- Centocor AggreStat ([K954997](/device/K954997.md))

## 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 (610) 853-1130

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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K962426](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K962426)

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