# K092749: Mas and Mini-Trol PTH Control

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Dec 3, 2009 after 86 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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: 3 generations back to K891475 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043108: Liquichek Specialty Immunoassay Control, Bio-Rad Laboratories, Inc. (2004) Summary page 2.

## Indications for use
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Source page: https://510kreport.com/device/K092749
Methodology: https://510kreport.com/methodology