(28 days)
The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay.
The Elecsys® CalCheck™ AFP 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 document does not contain the detailed information necessary to answer your request. It's a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ AFP), which is a laboratory control, not a diagnostic device that would typically undergo the kind of performance studies you're asking about (e.g., studies with human readers, ground truth consensus, etc.).
The document focuses on:
- Device Name and Intended Use: The Elecsys® CalCheck™ AFP is used to verify the calibration of the Elecsys AFP assay.
- Predicate Device Comparison: It establishes substantial equivalence to a previously marketed calibration material (Elecsys® CalCheck™ TSH).
- Description: It's a three-level set of lyophilized, human-based materials to be assayed in triplicate.
The "Performance Characteristics" section is introduced but the actual details are cut off. However, even if they were present, for a calibration verification material, typical "performance" would involve things like:
- Value Assignment: How accurately the assigned values for the control material are determined.
- Stability: How long the lyophilized material and reconstituted material remain stable within specifications.
- Homogeneity: Ensuring consistent concentration throughout the material.
- Lot-to-lot consistency: Ensuring different manufacturing lots perform similarly.
It would not involve:
- A test set with ground truth established by experts.
- MRMC studies to evaluate human reader improvement.
- Standalone algorithm performance in a diagnostic context.
Therefore, I cannot provide the requested information based on the provided text.
{0}------------------------------------------------
MAR - 6 1997
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane name, Concord, CA 94524-4117 address. (510) 827 - 8215 contact Fax number: (510) 687-1850 Contact Person: Patricia Klimley Date Prepared: January 29, 1997 Proprietary name: Elecsys® CalCheck™ AFP 2. Device Name Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) The Elecsys® CalCheck™ AFP is substantially equivalent to the currently 3. Predicate marketed Elecsys® CalCheck™ CEA (K963147). device The Elecsys® CalCheck™ AFP is a three level single analyte set of 4. Device lyophilized, human based materials. After reconstitution, they are assayed in Description triplicate and the results compared to the target values. Continued on next page
{1}------------------------------------------------
510(k) Summary, Continued
| 5.Intended use | The Boehringer Mannheim Elecsys CalCheck AFP is used to verify thecalibration assignment for the Boehringer Mannheim Elecsys AFP assay. | |
|---|---|---|
| 6.Comparisonto predicatedevice | The Elecsys® CalCheck™ AFP is substantially equivalent to the currentlymarketed Elecsys® CalCheck™ TSH (K963147).The following table compares the Elecsys® CalCheck™ AFP with thepredicate devices, Elecsys® CalCheck™ TSH. Specific data on theperformance of the test have been incorporated into the draft labeling inattachment 5. Labeling for the predicate devices is provided in attachment 6. | |
| Similarities: | ||
| • Configuration: 3 CalCheck levels: low, mid, and high |
• Intended use: To verify calibration
Differences:
| Feature | CalCheck AFP | CalCheck TSH |
|---|---|---|
| Matrix type | Human serum | Horse serum |
| Analyte | AFP | TSH |
Continued on next page
{2}------------------------------------------------
510(k) Summary, Continued
Performance Characteristics:
- 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.