# K002128: Active Inhibin-a Elisa, Model DSL-10-28100

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Dec 5, 2000 after 144 days
- Product code: NDR (Enzyme Immunoassay, Inhibin-A)
- Device class: 1
- Regulation: 21 CFR 862.1260
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070144: Inhibin a Calibrators & Controls on the Access Immunoassay Systems (2007), 0 descendants of its own

## Recalls of this device
- Mar 31, 2011 · Not classified · Z-2774-2011: The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calib
- Mar 31, 2011 · Not classified · Z-2772-2011: The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calib
- Mar 31, 2011 · Not classified · Z-2773-2011: The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calib
- Mar 31, 2011 · Not classified · Z-2775-2011: The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calib

Source page: https://510kreport.com/device/K002128
Methodology: https://510kreport.com/methodology