# K960103: Dade Moni-Trol Candidate Product Combinations

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Apr 26, 1996 after 106 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
Longest line of descent: 1 generation back to K871977 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871977: Dade Moni-Trol Chemistry Control/Calibrator, American Dade (1987) Summary page 1.
- K891929: Moni-Trol (R), Baxter Healthcare Corp (1989) Summary page 1.
- (no number) Dade® Urine Chemistry Control: named in the summary without a submission number
- (no number) Dade® Immunoassay Control: named in the summary without a submission number
- (no number) Dade® Anemia/Hemochromatosis Control: named in the summary without a submission number
- (no number) Dade® CK/LD Control: named in the summary without a submission number
- (no number) BIO-RAD Lyphochek® Chemistry Control: named in the summary without a submission number
- (no number) Liquichek™ Immunology Control: named in the summary without a submission number
- (no number) Liquichek™ Rheumatoid Factor Control: named in the summary without a submission number
- (no number) CIBA-CORNING QCS® Control Serum: named in the summary without a submission number
- (no number) Boehringer Mannheim Precical®: named in the summary without a submission number
- (no number) Beckman CAL 1: named in the summary without a submission number

## Indications for use
Dade® Moni-Trol® Control is intended for use as an unassayed quality control material in quantitative clinical chemistry control programs. Dade® Moni-Trol® Control is intended to assist in the control of accuracy and precision of clinical chemistry quality control programs. Dade® Moni-Trol® Calibrator is intended for use as a calibrator in the quantitative determination of clinical assays.

Source page: https://510kreport.com/device/K960103
Methodology: https://510kreport.com/methodology