# K962629: Document Ammonia, Ethanol, Lactate Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Sep 13, 1996 after 70 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) New England Reagent Laboratory Ammonia Standards: named in the summary without a submission number
- (no number) Beckman Alcohol Kit Calibrator: named in the summary without a submission number
- (no number) Beckman CX Multi Calibrator: named in the summary without a submission number

## 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

## Indications for use
DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.

Source page: https://510kreport.com/device/K962629
Methodology: https://510kreport.com/methodology