(28 days)
The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.
The Elecsys® CalCheck™ PSA 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.
The provided text describes a medical device called "Elecsys® CalCheck™ PSA," a calibration verification material. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies).
The text focuses on establishing substantial equivalence to a predicate device (Elecsys® CalCheck™ TSH) based on configuration, intended use, and general performance characteristics like value assignment and stability, but it does not detail the quantitative performance of the Elecsys® CalCheck™ PSA against predefined acceptance criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from the provided text for the following reasons:
- No Acceptance Criteria Table or Reported Performance: The document does not explicitly state any quantitative acceptance criteria for the Elecsys® CalCheck™ PSA's performance. It mentions "specific data on the performance of the test have been incorporated into the draft labeling," but this data is not included in the provided text.
- No Study Details for Test Set: There is no mention of a specific study to prove performance against acceptance criteria, including sample sizes, data provenance (country of origin, retrospective/prospective), or how a test set was constructed.
- No Expert Details or Adjudication: The concept of "experts" to establish ground truth or "adjudication methods" is not applicable to this type of device (calibration verification material) as described in the provided text. Its function is to verify calibration, meaning its "ground truth" would be its assigned value, not an expert interpretation of, for example, an image.
- No MRMC or Standalone Study: The device is a calibration material, not an AI or diagnostic imaging device that would typically undergo Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
- Type of Ground Truth: The "ground truth" for a calibration material is its assigned value, determined through a specific manufacturing and assay process, not expert consensus, pathology, or outcomes data.
- No Training Set Details: Since this is a calibration verification material and not an AI algorithm, there is no concept of a "training set" or "how ground truth for the training set was established" in the context of the provided information.
In summary, the provided document is a 510(k) summary for a calibration verification material, which focuses on demonstrating substantial equivalence to a predicate device for its intended use rather than presenting a performance study against specific acceptance criteria in the manner requested.
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MAR - 6 1997
| 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. Klimley |
| Date Prepared: January 29, 1997 | |
| 2. Device Name | Proprietary name: Elecsys® CalCheck™ PSACommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Elecsys® CalCheck™ PSA is substantially equivalent to currently marketed, Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ PSA 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
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510(k) Summary, Continued
| 5.Intended use | The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay. | ||
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| 6.Comparisonto predicatedevice | The Elecsys® CalCheck™ PSA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147).The following table compares the Elecsys® CalCheck™ PSA with the predicate device, Elecsys® CalCheck™ TSH. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 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:
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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.