(53 days)
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System
CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL.
The provided document includes a section on "Performance Characteristics" specifically addressing the stability of the Dimension Vista™ System Chemistry 1 Calibrator. This section details the acceptance criteria for shelf-life stability and reports on how the device meets these criteria through a specific study design.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Analyte | Acceptance Criteria (Allowable Shelf life % change) | Reported Device Performance (Implied) |
|---|---|---|
| Urea Nitrogen | ≤ 5% | The study indicates that the "percent change over time is determined where the allowable shelf life percent change should be less than or equal to" these specified percentages. The subsequent statement, "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.", implies that the real-time data met or surpassed these acceptance criteria for the assigned 12-month shelf life. |
| Calcium | ≤ 5 % | |
| Cholesterol | ≤ 3% | |
| Creatinine | ≤ 5% | |
| Glucose | ≤ 5% | |
| Lactic Acid | ≤ 5% | |
| Magnesium | ≤ 3% | |
| Thyroxine | ≤ 6% | |
| Thyroxine Uptake | ≤ 6% | |
| Uric Acid | ≤ 5% |
The document also specifies acceptance criteria for on-board and open-vial stability:
- On-board stability: One day.
- Open vial (recapped and refrigerated): 30 days.
The reported performance for these is implied by the statement "A vial punctured by the instrument and stored on board has a stability claim of one day" and "An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 days." This suggests that testing was conducted and demonstrated compliance with these claims.
Study Proving Device Meets Acceptance Criteria:
The study described is a shelf-life stability study for the Dimension Vista™ Chemistry 1 Calibrator.
- Study Design/Methodology:
- Objective: To determine the target shelf life (12 months) of the calibrator and validate its stability under various conditions (long-term storage, on-board, and open-vial).
- Long-Term Shelf Life: Results of the product stored at 4°C are compared with a control stored at -20°C. The method is calibrated using the -20°C stored material, and the 4°C material values are recovered against this calibration. The percent change over time is monitored against the allowable shelf-life percent change criteria for each analyte. "Real-time data on file at Dade Behring, Inc." is used for the final shelf-life assignment.
- On-Board and Open-Vial Stability: Vials are opened/punctured on day zero. A sufficient quantity for multiple calibrations is removed. The vials are then recapped and stored at 2-8°C. These opened/punctured vials are tested on days 0, 8 hours, 2, 8, and 31, and their performance is compared against freshly opened vials.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of individual calibrator vials or batches used in the stability studies. For bottle value assignment, it mentions "N = 45 replicates" tested using multiple instruments. This refers to the assignment of final values to commercial lots, which is a part of quality control and verification, but not necessarily the sample size for the long-term stability testing itself. The sample size for the stability portion is not precisely quantified in the provided text, but it implies a longitudinal study over time.
- Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves monitoring the performance of the calibrator over time under controlled storage conditions to establish shelf life and stability claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is Not Applicable in this context. The device is a calibrator, and its performance (stability and value assignment) is assessed against analytical standards and reference materials (traceability to NIST SRMs, USP, CDC Abell-Kendall method), rather than expert interpretation of results on patient samples.
4. Adjudication Method for the Test Set
This information is Not Applicable. As the ground truth is based on analytical standards and reference methods, there is no need for expert adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is Not Applicable. No MRMC study was done, as this is a calibrator for an in vitro diagnostic chemistry system, not an imaging or diagnostic algorithm requiring human reader interpretation or comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is Not Applicable in the typical sense of an "algorithm." The calibrator itself is a physical product. Its performance is evaluated through a standalone stability study, where the calibrator's values are measured by instruments and compared against established analytical criteria, without human intervention in the result generation itself beyond the operation of the instrument and data analysis.
7. Type of Ground Truth Used
The ground truth for the performance (stability and value assignment) of the calibrator is based on:
- Analytical Standards and Reference Materials: Traceability to various certified reference materials such as:
- NIST SRM (National Institute of Standards and Technology - Standard Reference Material) for BUN, CA, CREA, GLU, MG, URCA, CHOL.
- CDC (Centers for Disease Control) Abell-Kendall reference method for CHOL.
- Lactic acid – lithium salt A-Grade for LA.
- USP (United States Pharmacopeia) for T4.
- Calculated Value: For TU.
- Previously Approved Master Pool/Standard Values: Used for verification of Master Pool/Standard values and stock solution values.
8. Sample Size for the Training Set
This information is Not Applicable. This product is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the calibrator is its manufacturing process to meet specific constituent concentrations, verified against reference materials.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable. As above, there is no "training set." The "ground truth" for the calibrator's composition and assigned values is established through gravimetric additions of reference materials to stock solutions and base matrices, followed by verification against primary standard materials, Master Pools, and previously approved Master Pool/Standard values, all traceable to the analytical standards listed in point 7. The final bottle values are assigned and verified by testing 45 replicates on multiple instruments against these established standards.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.