# K950469: Document Serum Multianalyte Calibration Verification Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Apr 11, 1995 after 67 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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.
48 later devices descend from it; 18 cite it directly.
0 of 49 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
- K992034: Document Thyroid Cal*Ver (1999), 29 descendants of its own
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 (2006), 26 descendants of its own
- K102904: Enhanced Estradiol (EE2) Master Curve Material (2010), 18 descendants of its own
- K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material (2011), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own

Source page: https://510kreport.com/device/K950469
Methodology: https://510kreport.com/methodology