(24 days)
Cliniqa Beta HCG Controls, Levels 1, 2, and 3 and Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.
Cliniqa Beta HCG Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Control a ready-to-use liguid control requiring no reconstitution or frozen storage.
Cliniqa Beta HCG Calibration Verification Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Calibration Verification Control a ready-to-use liquid control requiring no reconstitution or frozen storage.
Here's an analysis of the acceptance criteria and study information for the Cliniqa Beta HCG Control and Cliniqa Beta HCG Calibration Verification Control, based on the provided text:
Based on the provided K121237 510(k) summary, the device is a Quality Control Material (Assayed and Unassayed) for Beta HCG assays, not a diagnostic algorithm or image analysis device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of device submission.
The submission focuses on the performance characteristics relevant to a quality control material, primarily value assignment and stability.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device as a quality control material, the "acceptance criteria" are implied by the successful establishment of value assignment and stability claims.
| Acceptance Criteria (Implied for QC Material) | Reported Device Performance |
|---|---|
| Value Assignment Accuracy | The Mean and Expected Range for each method shall be presented in each lot-specific insert. These values are derived from analysis of vials representative of the entire lot, averaged from raw data. The Expected Range combines estimates of assay variance from participating laboratory data and other studies. This information is provided as a guide for laboratories. |
| Shelf-Life Stability | Cliniqa Beta HCG Control Level 1,2,3: |
- Accelerated Stability: Performed at 45°C and 37°C, supporting an initial claim of 3.6 years at 2-8°C.
- Real-time Stability: Ongoing testing at 2-8°C to support a claim of 3 years.
Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, 3:
- Accelerated Stability: Performed at 45°C and 37°C, supporting an initial claim of 3.6 years at 2-8°C.
- Real-time Stability: Ongoing testing at 2-8°C to support a claim of 3 years. |
| Open-Vial Stability | Cliniqa Beta HCG Control Level 1, 2, 3: Real-time testing supports a claim of 30 days stability at 2-8°C once opened.
Cliniqa Beta HCG Calibration Verification Control Level 1, 2, 3: Real-time testing supports a claim of 30 days stability at 2-8°C once opened. |
| Traceability | Traceability is dependent on the manufacturer of the reagents used for value assignment. Specifically, calibration of the Roche Elecsys HCG plus Beta reagent is standardized against the 4th International Standard for Chorionic Gonadotropin from the National Institute of Biological Standards and Control (NIBSC) code 75/589. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size in the context of typical "test set" for a diagnostic algorithm. For value assignment, it mentions "analysis of vials representative of the entire lot." For stability, it refers to "real-time and accelerated stability tests" and "real-time testing." The number of vials or measurements
is not detailed. - Data Provenance: Not specified as country of origin. The "participating laboratory data" for value assignment suggests multi-site input, but locations are not given. The traceability to NIBSC is an international standard.
- Retrospective or Prospective: Stability studies are typically prospective (real-time testing) and the accelerated tests are also designed to predict future stability. Value assignment would be done concurrently for each lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this device type. This is a quality control material where "ground truth" refers to the established values and stability claims, primarily determined through laboratory testing and reference to international standards.
4. Adjudication method for the test set
Not applicable. The "ground truth" for this device is based on analytical measurements and adherence to established scientific and manufacturing practices for quality control materials, not expert consensus on interpretations.
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
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
The "ground truth" for this product type is established through:
- Analytical Measurement: The mean and expected range for each lot are determined by averaging raw data obtained for each method using specific reagents and calibrators.
- Traceability to International Standards: The calibration of the Roche Elecsys HCG plus Beta reagent (used for value assignment) is standardized against the 4th International Standard for Chorionic Gonadotropin from NIBSC (code 75/589).
- Validated Stability Protocols: Real-time and accelerated stability study protocols determine the shelf-life and open-vial claims.
8. The sample size for the training set
Not applicable. This is a quality control material, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
§ 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.