CRYO CHECK FACTOR X DEFICIENT PLASMA

• K Number: K971227
• Device Name: CRYO CHECK FACTOR X DEFICIENT PLASMA
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1997-07-18 ( 107 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor X deficiencies in in vitro clot-based factor X assays using the one stage prothrombin time.

Device Description

CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits.

AI/ML Overview

This document is a 510(k) clearance letter for the "CryoCheck Factor X Deficient Plasma" device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy compared to a ground truth).

The letter merely states that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The described "Indications For Use" explain how the device functions to assess factor X deficiencies but do not provide performance metrics or details of a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or clinical trial summary.

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).