(27 days)
Elecsys CalCheck T Uptake is intended for use in the quantitative verification of the calibration curve established by the Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck T Uptake 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.
This document is a 510(k) summary for a medical device called "Elecsys® CalCheck™ T Uptake." It describes the device, its intended use, and its comparison to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
Specifically, the document focuses on:
- Introduction and Submitter Information: Standard administrative details.
- Device Name and Classification: Identifying the proprietary and common names, and classification.
- Predicate Device: Stating the device to which substantial equivalence is claimed (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862).
- Device Description: Explaining that it's a three-level single analyte set of lyophilized, human-based materials assayed in triplicate and compared to target values.
- Intended Use: For quantitative verification of the calibration curve established by Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
- Comparison to Predicate: Reaffirming substantial equivalence based on the same intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as it is not present in the provided text.
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K9 63181
510(k) Summary
Elecsys® CalCheck™ T Uptake
| 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 T Uptake |
| 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 T Uptake is a three level single analyte set oflyophilized, human based materials. After reconstitution they are assayed intriplicate and the results are compared to the target values. |
| 5) Intended use | Elecsys CalCheck T Uptake is intended for use in the quantitative verificationof the calibration curve established by the Elecsys T Uptake reagents andcalibrators on Elecsys 1010 or 2010 immunoassay analyzers. |
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510(k) Summary, Elecsys® CalCheck™ T Uptake, Continued
The Boehringer Mannheim Elecsys CalCheck T Uptake is substantially 6) Comparison to predicate equivalent to other products in commercial distribution intended for similar device 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 T Uptake 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.