# K964014: Kenlor H. Pylori Control Serum

- Pathway: 510(k) (Traditional)
- Applicant: Kenlor Industries, Inc.
- Decided: Mar 3, 1997 after 147 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- 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. The FDA summary names its predicate without a number.
- (no number) Commercial Serum Controls for H. pylori Antibody marketed with H. pylori antibody test kit by BioAmerica: named in the summary without a submission number
- (no number) Commercial Serum Controls for H. pylori Antibody marketed with H. pylori antibody test kit by Elias corporation: named in the summary without a submission number

## Indications for use
KENLOR H. pylori Serum Control is designed to provide unassayed precision control reagents. The controls are to be used with the in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls are designed for routine use to provide a means of estimating precision and monitoring system performance. The controls are not intended to replace reagent controls furnished with the commercial kits. The control should be used like a patient sample to assist in the assessment of the listed analytical procedures.

Source page: https://510kreport.com/device/K964014
Methodology: https://510kreport.com/methodology