(13 days)
Elecsys CalCheck FT4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck FT4 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 describes a 510(k) summary for a medical device called "Elecsys® CalCheck™ FT4". However, it does not contain any information regarding acceptance criteria, device performance, sample sizes, expert involvement, or study details.
The document focuses on:
- Introduction and Submitter Information: Basic details about the submission, company, and contact person.
- Device Name: Proprietary and common names, and classification.
- Predicate Device: Identification of a substantially equivalent device (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862).
- Device Description: A brief description of Elecsys CalCheck FT4 as a three-level, lyophilized, human-based material for calibration verification.
- Intended Use: Specifically states its purpose for quantitative verification of the calibration curve established by Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
- Comparison to Predicate Device: Reaffirms substantial equivalence based on intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert details, or study information as this data is entirely absent from the provided text.
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AUG 27 1996
510(k) Summary
Elecsys® CalCheck™ FT4
| 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 FT4 |
| 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 FT4 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 FT4 is intended for use in the quantitative verification ofthe calibration curve established by the Elecsys FT4 reagents and calibratorson Elecsys 1010 or 2010 immunoassay analyzers. |
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510(k) Summary, Elecsys® CalCheck™ FT4, Continued
- Comparison to predicate device
The Boehringer Mannheim Elecsys CalCheck FT4 is substantially equivalent to other products in commercial distribution intended for similar use. Most 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 FT4 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.