# K962176: TPP

- Pathway: 510(k) (Traditional)
- Applicant: Panbio, Inc.
- Decided: Oct 18, 1996 after 135 days
- Product code: MIF (Prothrombin Fragment 1.2)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K951143: Pulse Klystron Amplififer (L-5822-90), Litton Systems, Inc. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ABS, Inc. TpP™ EIA is an enzyme linked immunoassay for the quantitative determination of soluble fibrin polymers in human plasma. It is indicated as an aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy.

Source page: https://510kreport.com/device/K962176
Methodology: https://510kreport.com/methodology