DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS

K960103 · Dade Intl., Inc. · JIX · Apr 26, 1996 · Clinical Chemistry

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

Submission Summary (Full Text)

{0}

DADE

APR 26 1996

K900103

DADE INTERNATIONAL

X. Summary of Safety and Effectiveness

Dade International Inc.
P.O. Box 520672
Miami, FL 33152-0672

East: 305.633.6461
Fax: [phone]

West: 305.592.2311
Fax: [phone]

Darnell Center: 305.222.6200
Fax: [phone]

Submitter: Marian Harding Cochran, J.D., Regulatory Affairs Manager
Dade International Inc., Miami FL. 33172

Date: January 5, 1996

Device Names:

- Moni-Trol® Level 1 Chemistry Control and Carbonate Diluent 1, Moni-Trol® Level 2 Chemistry Control and Carbonate Diluent 2
- Moni-Trol® Level 1 Chemistry Control, Moni-Trol® Level 2 Chemistry Control and Moni-Trol® Level 3 Chemistry Control
- Moni-Trol® Level 1X Chemistry Control and Carbonate Diluent 1, Moni-Trol® Level 2X Chemistry Control and Carbonate Diluent 2
- Moni-Trol® Level 1X Chemistry Control, Moni-Trol® Level 2X Chemistry Control and Moni-Trol® Level 3X Chemistry Control
- Moni-Trol® Calibrator A and Carbonate Diluent 1, Moni-Trol® Calibrator B and Carbonate Diluent 2
- Moni-Trol® Calibrator A, Moni-Trol® Calibrator B and Moni-Trol® Calibrator C

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

Intended Uses:

- 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.

Comparison of the candidate device to the predicate devices: Comparison of intended uses, base material and constituents supports the determination of substantial equivalence.

Performance data: Non-clinical tests for typical analyte values, shelf-life and reconstituted stability submitted in the premarket notification support the conclusion that the candidate device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary.

Printed on recycled paper with 25% post-consumer fiber