# K050504: Validate Urine Chemistry Calibration Verification Test Sets

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Mar 25, 2005 after 25 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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) Summary page 1.
- K934357: Liquichek Routine Urime Chemistry Control, Levels 1 & 2, Bio-Rad (1993) Summary page 1.
- (no number) College of American Pathologists (CAP) Urine Chemistry Survey (Calibration Verification / Linearity) LN6-B 2004: named in the summary without a submission number

## Indications for use
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

Source page: https://510kreport.com/device/K050504
Methodology: https://510kreport.com/methodology