# K910440: Document Reflectance II Linearity Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: May 10, 1991 after 99 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.
41 later devices descend from it; 1 cites it directly.
0 of 42 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
- K023410: Validate Chem 10 Calibration Verification Test Set, Model 110 (2003), 40 descendants of its own
- K042318: Audit Microcv General Chemistry Linearity Set (2004), 39 descendants of its own
- K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5 (2010), 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
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own

Source page: https://510kreport.com/device/K910440
Methodology: https://510kreport.com/methodology