# K881773: Document (TM) Direct Ise Linearity Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Jun 10, 1988 after 45 days
- Product code: JJR (Electrolyte 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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
- K012117: Validate Chem 1 Calibration Verification Test Set, Model 10001 (2001), 5 descendants of its own
- K022401: PTS Panels Multi-Chemistry Controls (2002), 3 descendants of its own
- K090405: Lipidpro System (2009), 1 descendant of its own
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (2017), 0 descendants of its own
- K130295: Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System. (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K881773
Methodology: https://510kreport.com/methodology