# K971944: Lactest I

- Pathway: 510(k) (Traditional)
- Applicant: Jwt, Inc.
- Decided: Dec 17, 1997 after 204 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
LacTest™I is a lactic acid test system intended for use by healthy athletes for the determination of their lactate threshold. Lactate threshold is an important physiological parameter that reflects an individual’s capacity for sustained exercise. It has been used by coaches and trainers of elite athletes in a wide range of sports that involve aerobic exercise, to optimize the conditioning of the athlete.

Source page: https://510kreport.com/device/K971944
Methodology: https://510kreport.com/methodology