Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel

K161329 · Chrono-Log Corp. · JOZ · Dec 2, 2016 · Hematology

Device Facts

• Record ID: K161329
• Device Name: Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
• Applicant: Chrono-Log Corp.
• Product Code: JOZ · Hematology
• Decision Date: Dec 2, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

Indications for Use

The Chrono-log Platelet Aggregometer, Model 490 4+4 is intended for use in the clinical laboratory to measure platelet aggregation in platelet rich plasma (PRP) by light transmission aggregometry.

Device Story

Chrono-log Platelet Aggregometer Model 490 4+4; modified version of Model 700 (K050265). Device performs platelet aggregation via light transmission aggregometry; reduced functionality compared to predicate (removed impedance and luminescence capabilities). Features increased sample channels; smaller chassis size. Used in clinical laboratories by trained personnel. Input: platelet rich plasma samples. Output: platelet aggregation measurements. Clinical utility: assessment of platelet function. Substantial equivalence established via design control activities, risk analysis per ISO 14971, and comparative performance studies using normal/abnormal samples.

Clinical Evidence

Bench testing only. Comparison study performed between candidate device and predicate device using normal and abnormal samples to demonstrate substantial equivalence. Software verification and validation documentation provided.

Technological Characteristics

Optical platelet aggregometer using infrared light transmission. Features four channels, heater blocks (maintained at 37°C), and silicon photodiode detectors. Connectivity via strip chart recorder or computer interface. Tactile membrane switch controls and LCD display. Firmware-controlled phase-locked stirring motor speed. No luminescence or impedance measurement capabilities.

Indications for Use

Indicated for in-vitro diagnostic measurement of platelet aggregation in platelet-rich plasma (PRP) in clinical laboratory settings by technicians. Used for Ristocetin Cofactor Assay to aid in von Willebrand disease diagnosis.

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 Lumi-Aggregometer, Model 700 (K050265)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K161329

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Chrono-log Whole Blood Lumi-Aggregometer, Model 700, K050265.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for introduction of the Chrono-log Platelet Aggregometer, Model 490 4+4 by modification of the submitter's previously cleared device. The modifications of the previously cleared device include removal of device components to reduce the functions of the device from platelet aggregation by light transmission aggregometry, platelet aggregation by impedance in whole blood, and ATP release by luminescence to only performing platelet aggregation by light transmission aggregometry. In addition, component upgrades to the device were made to allow for an increase in the number of sample channels and smaller chassis size.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, intended use, assay procedure, reagents, instruments, and software.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis: The Risk Analysis was conducted in accordance with ISO 14971, Medical devices – Application of risk management to medical devices.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied: Software verification and validation documentation was provided in the submission. In addition, a comparison study with normal and abnormal samples was performed between the candidate device and the predicate device. The comparison data generated provide evidence that the candidate device and the predicate device are substantially equivalent.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.