# K063323: Spectrolyse Pai-1, Model 101201

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Aug 15, 2007 after 285 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922782 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922782: Spectrolyse/PL Pai Kit, Biopool AB (1992) Summary page 1.

## Recalls of this device
- Oct 24, 2012 · Class II · Z-0463-2013: Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
- Aug 28, 2012 · Class II · Z-2431-2012: SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dil

## Indications for use
Spectrolyse®PAI-1 kit, Product # 101201, is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-I (PAI-I) activity in human plasma. The test is for in vitro diagnostic use and is not intended for internal use in humans and animals.

Source page: https://510kreport.com/device/K063323
Methodology: https://510kreport.com/methodology