(120 days)
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No
The device description details a purely electrical impedance-based measurement system with a direct proportional output displayed on a readout or strip chart. There is no mention of any computational analysis, pattern recognition, or learning algorithms that would indicate the use of AI/ML.
No
The device is used to measure platelet function in a whole blood specimen, which is a diagnostic purpose, not a therapeutic one. It analyzes a sample rather than treating a condition.
Yes
The device is described as "intended for determination of platelet function in a whole blood specimen," which is a diagnostic purpose to assess a physiological state (platelet function).
No
The device description explicitly details hardware components (electrode with platinum alloy wires, voltage application, front panel readout, analog output) and a physical measurement method (electrical impedance) applied to a whole blood sample. This is not a software-only device.
Yes, based on the provided information, the Chrono-log WBA, Model 591/592 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is for the "determination of platelet function in a whole blood specimen." This involves testing a biological sample (whole blood) taken from the body to provide information about a physiological state (platelet function).
- Device Description: The device measures platelet aggregation in a whole blood sample using electrical impedance. This is a laboratory-based test performed on a sample outside of the living organism.
- Predicate Devices: The listed predicate devices (Chrono-log Whole Blood Aggregometer and Centocor AggreStat) are also IVD devices used for similar in vitro platelet function testing.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Chrono-log WBA, Model 591/592 uses electrical impediance 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 applies 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 aggreazate 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 duel channel version.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 864.5700 Automated platelet aggregation system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 impediance 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 applies 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 aggreazate 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 duel channel version.
Intended Use:
The Chrono-log WBA, Model 591/592 is intended for determination of platelet function in a whole blood specimen.