# K961929: Factor Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Universal Reagents, Inc.
- Decided: Oct 10, 1996 after 146 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893523 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924394: Clotting Factor V Deficient Plasma, Behring Diagnostics, Inc. (1992) Summary page 1.
- K924396: Clotting Factor-Viii-IX-XI-Xii Deficient Plasma, Behring Diagnostics, Inc. (1993) Summary page 1.
- K924400: Clotting Factor-11,-Vii, -X Deficient Plasma, Behring Diagnostics, Inc. (1993) Summary page 1.
- K893523: Factor X Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K893524: Factor IX Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K893525: Factor Viii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K893533: Factor V Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K893534: Factor Xii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K893535: Factor Vii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989)
- K893536: Factor XI Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K900133: Factor II Deficient Plasma, Medical Diagnostic Technologies, Inc. (1990) Summary page 1.

## Indications for use
Factor deficient plasma, Factor - Il, V, VII, VIII, IX, X, Xi, XIl, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor Vlil is human plasma and bovine material.

Source page: https://510kreport.com/device/K961929
Methodology: https://510kreport.com/methodology