(13 days)
Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers
The Elecsys CalCheck T4 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
The provided text is a 510(k) summary for the "Elecsys® CalCheck™ T4," a calibration verification material. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.
This document pertains to a calibration verification material, which is a control used to ensure the accuracy of an immunoassay analyzer. The "study" mentioned here refers to the comparison of this new calibration material to a predicate device, focusing on its intended use for calibration verification rather than clinical diagnostic performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device for a calibration verification product, not on clinical performance studies of a diagnostic algorithm or device where the questions posed would be relevant.
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K96 3178
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AUG 27 1996
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510(k) Summary
Elecsys® CalCheck™ T4
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
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| 1) Submitter name, address, contact | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: John D. StevensDate Prepared: August 12, 1996 |
| 2) Device name | Proprietary name: Elecsys CalCheck T4Common name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3) Predicate device | We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers |
| 4) Device Description | The Elecsys CalCheck T4 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values. |
| 5) Intended use | Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers |
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510(k) Summary, Elecsys® CalCheck™ T4, Continued
The Boehringer Mannheim Elecsys CalCheck T4 is substantially equivalent 6) Comparison to predicate to other products in commercial distribution intended for similar use. Most device notably it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862.
The intended use of both the Elecsys CalCheck T4 and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.