(10 days)
Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck TSH 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 does not contain information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) summary for a calibration verification material (Elecsys CalCheck TSH), focusing on its intended use and establishing substantial equivalence to a predicate device.
Therefore, I cannot populate the requested tables and answer the questions based on the given input.
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| AUG 23 1996 | 510(k) Summary |
|---|---|
| Elecsys® CalCheck™ TSH | |
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| 1) Submittername, address,contact | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000 |
| Contact Person: John D. Stevens | |
| Date Prepared: August 12, 1996 | |
| 2) Device name | Proprietary name: Elecsys CalCheck TSH |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3) Predicatedevice | We claim substantial equivalence to the Tosoh Medic AIA-Pack HCGCalibration Verification Test Set, K924862. The intended use for bothproducts is to verify the calibration curve of automated immunoassayanalyzers |
| 4) DeviceDescription | The Elecsys CalCheck TSH is a three level single analyte set of lyophilized,human based materials. After reconstitution they are assayed in triplicate andthe results are compared to the target values. |
| 5) Intended use | Elecsys CalCheck TSH is intended for use in the quantitative verification ofthe calibration curve established by the Elecsys TSH reagents and calibratorson Elecsys 1010 or 2010 immunoassay analyzers. |
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510(k) Summary, Elecsys® CalCheck™ TSH, Continued
- Comparison The Boehringer Mannheim Elecsys CalCheck TSH is substantially equivalent 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 TSH 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.