# K972146: Qualitrol Unassayed H. Pylori Control Set Positive and Negative Controls

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technologies, Inc.
- Decided: Jul 8, 1997 after 29 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used; (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.

Source page: https://510kreport.com/device/K972146
Methodology: https://510kreport.com/methodology