DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
Device Facts
| Record ID | K960103 |
|---|---|
| Device Name | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS |
| Applicant | Dade Intl., Inc. |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Apr 26, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended 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.
Device Story
Moni-Trol® products function as quality control materials and calibrators for clinical chemistry assays; used in clinical laboratories to verify accuracy and precision of quantitative test results; products consist of chemistry controls (Levels 1, 2, 3, 1X, 2X, 3X) and calibrators (A, B, C) often paired with carbonate diluents; healthcare professionals use these materials to validate instrument performance and ensure reliable patient diagnostic data; benefits include standardized assay calibration and ongoing monitoring of analytical system stability.
Clinical Evidence
Bench testing only. Data provided includes typical analyte values, shelf-life, and reconstituted stability testing to support safety and effectiveness claims.
Technological Characteristics
Lyophilized or liquid chemistry control and calibrator materials; includes carbonate diluents for reconstitution; intended for quantitative clinical chemistry applications.
Indications for Use
Indicated for use as quality control material and calibrator in quantitative clinical chemistry assays to monitor accuracy and precision of laboratory testing.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Dade® Moni-Trol® Chemistry Control / Calibrator (K871977)
- Moni-Trol® and Other Brand names Chemistry Control / Calibrator (K891929/A)
- Dade® Urine Chemistry Control
- Dade® Immunoassay Control
- Dade® Anemia/Hemochromatosis Control
- Dade® CK/LD Control
- BIO-RAD Lyophochek® Chemistry Control
- Liquichek™ Immunology Control
- Liquichek™ Rheumatoid Factor Control
- CIBA-CORNING QCS® Control Serum
- Boehringer Mannheim Precal®
- Beckman CAL 1
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