# K971428: Coagulation Control Plasma (Abnormal)Level 0

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Jun 17, 1997 after 61 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dade® Ci-Trol® Coagulation Control, Level I: named in the summary without a submission number

## Indications for use
Hemostasis Control Plasma (Abnormal) Level Theta is intended for use in a laboratory program of quality assurance for APTT and PT results with short clotting times. PT and APTT clotting times at the low end, or below the locally determined normal reference range are often related to the presence of elevated levels of fibrinogen and factor VIII. Both of these proteins are elevated in response to an inflammatory stimulus, malignant disease process or trauma. Control Level Theta plasma provides a means for verifying the lower extent of the reportable range of the PT and APTT, particularly the imprecision of short clotting times often encountered with these screening tests.

Source page: https://510kreport.com/device/K971428
Methodology: https://510kreport.com/methodology