CRYOCHECK CLOT C

• K Number: K040987
• Device Name: CRYOCHECK CLOT C
• Manufacturer: PRECISION BIOLOGIC INC.
• Date Cleared: 2004-06-18 ( 64 days)
• Product Code: GGP
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: K861079

Intended Use

CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

Device Description

CryoCheck Clot C consists of: Protein C Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein C by immunoadsorption. Clot C Activator - Contains protein isolated from the venom of Agkistrodon contortrix capable of activating protein C in human plasma, Russell's viper venom, phospholipids, heparin neutralizing agents, buffers and stabilizers. CS Diluent (provided separately by Precision BioLogic).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CryoCheck Clot C device, extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Quantitative determination of protein C activity in citrated human plasma.	CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma. (Matches predicate)
Correlation with Predicate Device	Substantial equivalence demonstrated by a strong correlation (R value).	R = 0.9142 when compared to STA - Staclot Protein C.
Assay Format	Not explicitly stated as a numerical criterion, but expected to be effective.	Frozen
Volume	Not explicitly stated as a numerical criterion.	• 5 x 3.0 mL Protein C Deficient Plasma
• 5 x 3.0 mL Clot C Activator
OR
• 5 x 1.0 mL Protein C Deficient Plasma
• 5 x 1.0 mL Clot C Activator

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with numerical performance thresholds. The "acceptance criteria" are therefore inferred from the comparison study's objective to show equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 119 clinical samples.
• Data Provenance: The document states "clinical samples," implying human patient samples, but does not specify the country of origin or whether they were retrospective (previously collected) or prospective (collected specifically for the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not mention the use of experts to establish ground truth for the test set. The comparison is made against a predicate device, implying the predicate device's results serve as the reference or "ground truth" for correlation.

4. Adjudication Method for the Test Set:

• Not applicable. The study is a direct comparison to a predicate device, not an expert-driven adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• Not applicable. This device is a clot-based assay (an in-vitro diagnostic test measuring a protein in plasma), not an AI-powered imaging or diagnostic tool requiring human reader interpretation. Therefore, an MRMC study or AI assistance is not relevant to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This is an assay performed in a laboratory, not an algorithm. The "standalone" performance is effectively the performance of the assay itself as described in the correlation study.

7. The Type of Ground Truth Used:

• The ground truth for the comparison study was the results obtained from the STA - Staclot Protein C (K861079) predicate device. The study correlated the CryoCheck Clot C results with those of the predicate device using clinical samples.

8. The Sample Size for the Training Set:

• Not applicable. This is an in-vitro diagnostic assay, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set was used.

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).