# K022401: PTS Panels Multi-Chemistry Controls

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Aug 21, 2002 after 29 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
Longest line of descent: 2 generations back to K870252 (1987). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012117: Validate Chem 1 Calibration Verification Test Set, Model 10001, Maine Standards Co. (2001)
- K012119: Validate Chem 3 Calibration Verification Test Set, Model 10003, Maine Standards Co. (2001)

## Most influential descendants
- 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

## Indications for use
The PTS PANELS .)fulti-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may anse from reagent or analytical instnunent variation and are intended for use by healthcare professionals in both physicians' oEces and in acute and convalescent care facility bedside testing as well as consumers at home.

Source page: https://510kreport.com/device/K022401
Methodology: https://510kreport.com/methodology