(59 days)
Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.
Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.
The provided document is a 510(k) summary for a medical device called "Drug Calibrator II." This document describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does not contain any information regarding acceptance criteria or a study that evaluates the device's performance against such criteria. It is a regulatory submission focused on demonstrating substantial equivalence for an in vitro diagnostic calibrator, not a study report detailing performance metrics.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To be clear, the document:
- Does not include a table of acceptance criteria and reported device performance.
- Does not specify sample sizes for a test set, data provenance, or details about a study design.
- Does not mention experts, ground truth establishment methods, or adjudication.
- Does not discuss MRMC comparative effectiveness studies or standalone algorithm performance.
- Does not provide details on training set size or ground truth establishment for a training set.
The document is purely a descriptive regulatory filing for a calibrator product.
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Image /page/0/Picture/0 description: The image contains the word "DADE" in large, bold, black letters. Below the word "DADE" is the handwritten number "K962817". In the upper right corner of the image, the text "SEP 16 1986" is visible.
DADE INTERNATIONAL
Chemistry Systems P.O. Box 6101 Newark, DE 19714
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Drug Calibrator II
Summary of Safety and Effectiveness
Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.
Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.
Drug Calibrator II is substantially equivalent to the Dimension® Drug Calibrator as they are both intended to be used as calibrators for drug methods and are spiked with purified drugs.
Carolyn K. George
Caroly K. George Regulatory Affairs and Compliance Manager
July 18, 1996
Date
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.