(106 days)
Not Found
No
The document describes a quality control material and calibrator for clinical chemistry, with no mention of AI or ML in its intended use, device description, or performance studies.
No
The device is a quality control material and calibrator used for clinical chemistry assays, not for diagnosing, treating, or preventing disease in patients.
No
Explanation: The device is described as an unassayed quality control material and a calibrator, intended to assist in the control of accuracy and precision of clinical chemistry quality control programs. It is not used to diagnose a patient's condition.
No
The device is described as a "quality control material" and "calibrator" for clinical chemistry programs, which are physical substances used for testing and calibration, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for use "in quantitative clinical chemistry control programs" and "in the quantitative determination of clinical assays." These are activities performed in vitro (outside the body) to analyze samples for clinical purposes.
- Device Name: The name "Dade® Moni-Trol® Control" and "Dade® Moni-Trol® Calibrator" are typical names for quality control and calibration materials used in clinical laboratory settings.
- Predicate Devices: The listed predicate devices are also IVD products (e.g., Chemistry Control/Calibrator, Urine Chemistry Control, Immunoassay Control). This further supports the classification of this device as an IVD.
The description clearly indicates that this product is used in a laboratory setting to ensure the accuracy and precision of clinical chemistry tests, which is a core function of IVD devices.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 of minereled page than the legally marketed devices identified in this summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dade® Moni-Trol® Chemistry Control / Calibrator (K871977), Moni-Trol® and Other Brand names Chemistry Control / Calibrator, (K891929/A)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
DADE
APR 26 1996
K960103
DADE INTERNATIONAL
Dade International Inc. P.O. Box 520672 Miami, FL 33152-0672
East: 305.633.6461 Fax: 305.637.6802
West: 305.592.2311 Fax: 305.591.5552
Darnell Center: 305.222.6200 Fax: 305.222.6222
X. Summary of Safety and Effectiveness
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 Precical®
- 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 of minereled page than the legally marketed devices identified in this summary.