# K924493: Document Total and Direct Bilirubin Linearity-Mod

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Jan 11, 1993 after 136 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004 (2001), 3 descendants of its own
- K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set (2009), 1 descendant of its own
- K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (2016), 0 descendants of its own
- K041975: Validate Lipoprotein Calibration Verification Test Set, Model 501 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K924493
Methodology: https://510kreport.com/methodology