# K012117: Validate Chem 1 Calibration Verification Test Set, Model 10001

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Aug 20, 2001 after 45 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: 1 generation back to K870252 (1987). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870252: Document (TM) Multi-Analyte Linearity Test Set, Casco Standards (1987) Summary page 1.
- K881773: Document (TM) Direct Ise Linearity Test Set, Casco Standards (1988) Summary page 1.
- K893142: Document (TM) Iron, Magnes, Trigly Linear Test Set, Casco Standards (1989) Summary page 1.
- K962629: Document Ammonia, Ethanol, Lactate Calibrator, Casco Standards (1996) Summary page 1.
- (no number) Precitrol Ethyl Alcohol/Ammonia/Lactate Control: named in the summary without a submission number

## Most influential descendants
- 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
- K050504: Validate Urine Chemistry Calibration Verification Test Sets (2005), 0 descendants of its own

## Indications for use
The VALIDATE Chem 1 Calibration Verification Test Set is 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 fcllowing analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.

Source page: https://510kreport.com/device/K012117
Methodology: https://510kreport.com/methodology