(28 days)
The Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.
The Elecsys® CalCheck™ CEA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.
This is a pre-AI/ML device, and the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance. The device is a calibration verification material for an immunoassay. Therefore, I cannot fulfill your request based on the provided input.
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MAR – 6 1997
510(k) Summary
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.
| 1.Submitter name, address, contact | Boehringer Mannheim Corporation2400 Bisso LaneConcord, CA 94524-4117(510) 827 - 8215Fax number: (510) 687-1850Contact Person: Patricia M. KlimleyDate Prepared: January 29, 1997 |
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| 2.Device Name | Proprietary name: Elecsys CalCheck CEACommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.Predicate device | The Elecsys® CalCheck™ CEA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). |
| 4.Device Description | The Elecsys® CalCheck™ CEA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values. |
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510(k) Summary, Continued
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| 5.Intended use | The Elecsys® CalCheck™ CEA is used to verify the calibration assignmentfor the Elecsys® CEA assay. |
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| 6.Comparisonto predicatedevice | The Elecsys® CalCheck™ CEA is substantially equivalent to the currentlymarketed Elecsys® CalCheck™ TSH (K963147). |
| The following table compares the Boehringer Mannheim Elecsys®CalCheck™ CEA with the predicate device, Elecsys® CalCheck™ TSH.Specific data on the performance of the test have been incorporated into thedraft labeling in attachment 5. Labeling for the predicate devices is providedin attachment 6. | |
| Similarities: | |
| • Configuration: 3 CalCheck levels: low, mid, and high | |
| • Intended use: To verify calibration | |
| Differences: |
| Feature | CalCheck CEA | CalCheck TSH |
|---|---|---|
| Matrix type | Human serum | Horse serum |
| Analyte | CEA | TSH |
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Performance Characteristics: 6. Comparison to predicate device, (cont.) • Value assignment and stability
§ 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.