(15 days)
The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay.
The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS.
This is a calibration verification product, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable as these concepts are specific to AI/ML device evaluations.
The provided text describes a "Calibration Verification Material" (Elecsys CalCheck Testosterone) used to verify the calibration assignment for an assay. Its performance is evaluated based on "value assignment and stability."
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JAN 300 1997
510(k) Summary
BOEHRINGER
MANNHEIM
CORPORATION
| 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) 674-0690 extension 8413Fax number: (510) 674-0690, x8413Contact Person: Yvette LloydDate Prepared: January 13, 1997 |
| 2.Device Name | Proprietary name: Elecsys CalCheck TestosteroneCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.Predicate device | The Boehringer Mannheim Elecsys CalCheck Testosterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4.Device Description | The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS. |
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BOEHRINGER
MANNHEIM
CORPORATION
| 5.Intended use | The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay. |
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| 6.Comparisonto predicatedevice | The Boehringer Mannheim Elecsys® CalCheck™ Testosterone 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 FSH Calibration Verification Test. (K924863) |
| Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. | |
| 7. PerformanceCharacteristics | The Elecsys® CalCheck™ Testosterone was evaluated for value assignment and stability. |
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§ 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.