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510(k) Data Aggregation
(77 days)
For use in calibration of the Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid assays.
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. The MCC contains 13 analytes in a liquid human serum based matrix. The concentrations and activities are suitable for calibration of the Abbott ARCHITECT c8000 System. Constituent concentrations are available at 2 levels.
A multi-Analyte Calibrator - human serum based, liquid ready-to-use calibrator containing Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid.
The document describes modifications to an existing calibrator device, the Abbott Clinical Chemistry Multiconstituent Calibrator (MCC), by adding three new analytes: Iron, Lactate, and Magnesium. The study aims to demonstrate that the modified device is substantially equivalent to the original MCC (K981706) and that these modifications do not significantly change its safety and effectiveness.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | For each analyte, system suitability (validity) is verified by calibrating and testing controls with pre-defined ranges. The mean value obtained for the reference standard solution must be within 5% from the known standard concentration. | The testing was performed independently for each analyte using one Abbott Architect c8000 System. System suitability was verified. NIST standards (and other specified reference materials) were used for applicable analytes. 20 replicates of each tested calibrator level and each respective standard solution were tested. Mean analyte values were calculated. The system was calibrated with the newly assigned mean analyte values and reference standard solutions were measured. Implicitly, the results met the 5% acceptance criterion, as the conclusion states the modified device is substantially equivalent to the predicate. |
| Shelf-life Stability | 20 months from the date of manufacture. | Data to support a shelf-life stability of 20 months was established by accelerated stability studies on Architect c8000 Systems. The document states this was demonstrated by comparison with the predicate device. |
| Open-vial Stability | 7 days when stored at 2 to 8 °C or 24 hours when stored at 15 to 30 °C. The stability claims of the previous formulation and traceability to the same reference methods were demonstrated to be substantially equivalent to the predicate device. | Open-vial stability was established by incubating opened calibrator vials at 30°C for 28 days with 3 calibrator lots. Results of the open vials (means of at least three replicates) were compared to those of freshly opened calibrator vials. Implicitly, the results supported the 7-day at 2-8°C and 24-hour at 15-30°C claims, as the conclusion states the modified device is substantially equivalent. |
| Substantial Equivalence | The modified device is substantially equivalent to the original Multiconstituent Calibrator (K981706). Modifications should not significantly change the safety and effectiveness of the device. | "The modified Abbott Clinical Chemistry Multiconstituent Calibrator (MCC) is substantially equivalent to the original Multiconstituent Calibrator as demonstrated by results obtained in the studies." The report explicitly states the modifications (addition of Iron, Lactate, Magnesium) did not significantly change the safety and effectiveness of the device. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Value Assignment Test Set: For each analyte, 20 replicates of each tested calibrator level and each respective standard solution were tested.
- Open-vial Stability Test Set: 3 calibrator lots were used. For each lot, results were assessed from "means of at least three replicates."
- Shelf-life Stability Test Set: The document does not specify the exact sample size (number of lots or replicates) for the accelerated stability studies, only that they were performed on "Architect c8000 Systems."
- Data Provenance: The document does not explicitly state the country of origin. The submitter is Abbott Laboratories in Irving, TX, USA. The studies appear to be prospective in nature, as they were conducted to demonstrate equivalence for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable in the conventional sense for this type of device. This device is a calibrator, and its "ground truth" or reference values are established through rigorous analytical methods (e.g., gravimetric, coulometric titration, IDMS) against recognized reference materials and standards (e.g., NIST SRMs). The expertise involved would be in analytical chemistry and metrology, not clinical interpretation by expert readers.
4. Adjudication Method for the Test Set
- Not applicable. This study does not involve subjective interpretations requiring adjudication (like image analysis or clinical diagnosis). The "truth" is determined by objective analytical measurements compared to highly accurate reference standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a Class II in vitro diagnostic calibrator, not an AI-powered diagnostic device used by human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable Directly. While the "performance" of the calibrator itself is standalone (meaning, it functions mechanically and chemically as described), it's not an AI algorithm. The performance evaluation focuses on its analytical accuracy and stability when used with the Abbott ARCHITECT c8000 System.
7. The Type of Ground Truth Used
- Reference Materials/Standards and Reference Methods:
- NIST Standards (National Institute of Standards and Technology Standard Reference Materials): Examples include NIST SRM 956 for Calcium and Magnesium, NIST SRM 967 and 914 for Creatinine, NIST SRM 965 for Glucose, NIST SRM 3126 for Iron, NIST SRM 909 for Urea Nitrogen and Uric Acid.
- ERM-DA470: For Albumin.
- Human Cholesterol (Abell-Kendall verification): For Cholesterol.
- Reagent grade lactate: For Lactic Acid.
- NIST 186-1/2186-I: For Phosphorus.
- NIST SRM 927: For Total Protein.
- ACS Grade Glycerol: For Triglyceride.
- Reference Methods: Such as Gravimetric, Coulometric Titration, Isotope Dilution Mass Spectrometry (IDMS), and Volumetric methods are used to establish the values traceable to these reference materials.
8. The Sample Size for the Training Set
- Not applicable. This is a calibrator, not a machine learning model. There is no "training set" in the context of AI. The manufacturing and validation processes involve extensive quality control and verification, but not model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As a calibrator, its "true" values are established through metrologically sound procedures using primary reference materials and methods, as detailed in point 7.
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