# K993332: Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05

- Pathway: 510(k) (Traditional)
- Applicant: Gradipore, Ltd.
- Decided: Feb 16, 2000 after 135 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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
Longest line of descent: 1 generation back to K961370 (1996). 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)
- K961370: LA Positive Control Plasma, Medical Diagnostic Technologies, Inc. (1996) Summary page 1.

## Indications for use
GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments.

Source page: https://510kreport.com/device/K993332
Methodology: https://510kreport.com/methodology