(16 days)
The Boehringer Mannheim Elecsys CalCheck Progesterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Progesterone assay.
The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS.
The provided text is for a calibration verification material (Elecsys CalCheck Progesterone), not a diagnostic device with performance metrics like sensitivity, specificity, or AUC typically found in medical imaging or AI studies. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Value Assignment: Accurate and reliable value assignment. | The calibrators are in-process checked and quality controlled against Enzymun® Progesterone assay kit calibrators. These assay kit calibrators have been value assigned by comparison to ID-GC/MS (Isotope Dilution Gas Chromatography/Mass Spectrometry), which is a highly accurate reference method. |
| Verification of Calibration: Ability to verify the calibration assignment for the Boehringer Mannheim Elecsys Progesterone assay. | Not explicitly stated as a numerical performance metric (e.g., % of successful verifications), but the intended use implies it meets this. The document focuses on the process of value assignment, which underpins its ability to perform this verification function. |
| Stability: Maintain assigned values over time. | The device was "evaluated for value assignment characteristics and stability." No specific stability data (e.g., shelf-life, expiration period with associated data) is provided in this summary, but the mention indicates an assessment was performed. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The description mentions "calibrators are in process checked and quality controlled," suggesting ongoing internal testing rather than a single, defined "test set" in the context of a diagnostic study.
- Data Provenance: Not specified. It's likely internal Boehringer Mannheim data, but no country of origin or retrospective/prospective nature is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" (value assignment) is established through a laboratory method (ID-GC/MS) rather than expert human interpretation.
- Qualifications of Experts: N/A
4. Adjudication method for the test set
- Adjudication method: Not applicable. Ground truth is established by a reference analytical method, not human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This is a calibration material, not a diagnostic device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical reagent used in an assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for value assignment is established by Isotope Dilution Gas Chromatography/Mass Spectrometry (ID-GC/MS). This is a highly accurate and precise analytical reference method for quantitative measurements.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an algorithm that undergoes a training process.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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| APR -2 1997 | |
|---|---|
| K970984 |
BOEHRINGER
MANNHEIM Summary
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) 687-1850Contact Person: Yvette Lloyd |
|---|---|
| Date Prepared: March 13, 1997 | |
| 2.Device Name | Proprietary name: Elecsys CalCheck ProgesteroneCommon name: Calibration Verification MaterialClassification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.Predicate device | The Boehringer Mannheim Elecsys CalCheck Progesterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4.Device Description | The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS. |
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Summary, Continued CORPORATION
| 5.Intended use | The Boehringer Mannheim Elecsys CalCheck Progesterone is used to verifythe calibration assignment for the Boehringer Mannheim Elecsys Progesteroneassay. |
|---|---|
| 6.Comparisonto predicatedevice | The Boehringer Mannheim Elecsys® CalCheck™ Progesterone issubstantially euivalent to other products in commercial distribution intendedfor similar use. Most notably, it is substantially equivalent to the currentlymarketed Tosoh Medics AIA-Pack FSH Calibration Verification Test.(K924863) |
| Both products are intended to be used for the verification of calibration foranalytes on automated immunoassay analyzers. | |
| 7. Performance | The Elecsys® CalCheck™ Progesterone was evaluated for value assignment |
- I crior mance - The Liccsyse
Characteristics and stability.
ដើ
§ 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.