(117 days)
The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.
This is a liquid, ready-to-use, multi analyte, IVD calibrator. The SYNCHRON Multi Calibrator is prepared in a human serum matrix which is stabilized by the use of ethylene glycol. During manufacture, the multiple constituents are spiked into the matrix at the desired concentration levels. The analyte(s) in this calibrator is traceable using prEN ISO 17511 to the reference materials listed below.
The provided document is a 510(k) summary for the SYNCHRON® Systems SYNCHRON Multi Calibrator. This device is a multi-analyte IVD calibrator. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic test's accuracy, sensitivity, or specificity.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a calibrator.
However, I can extract information related to the device's technical specifications and the comparison to its predicate.
Here's the information that can be extracted and how it relates to "acceptance criteria" for a calibrator in this context:
1. A table of acceptance criteria and the reported device performance
For a calibrator, "performance" is demonstrated by its inherent properties, traceability, value assignment, and stability, rather than clinical performance metrics. The acceptance criteria essentially stem from being substantially equivalent to the predicate and meeting established traceability standards.
| Acceptance Criteria (Implied by Regulatory Submission) | Reported Device Performance (Provided in document) |
|---|---|
| Intended Use: Calibration of specific analytes on SYNCHRON Systems. | The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. This is comparable to the predicate's intended use for similar analytes. |
| Matrix base: Human serum, stabilized with ethylene glycol. | The calibrator is prepared from human serum and stabilized by the use of ethylene glycol. (Identical to predicate). |
| Levels: Single level calibrator. | 1 (Identical to predicate). |
| Form: Liquid, ready to use. | Liquid, ready to use (Identical to predicate). |
| Open vial stability: 20 days at +2°C to +8°C. | 20 days at +2°C to +8°C (Identical to predicate). |
| Storage: -15°C to -20°C. | -15°C to -20°C (Identical to predicate). |
| Packaging: 6 X 20 mL bottles. | 6 X 20 mL bottles (Identical to predicate). |
| Real time stability: 24 months. | 24 months (Identical to predicate). |
| Traceability: Analytes are traceable to recognized reference materials. | Analytes are traceable using prEN ISO 17511 to reference materials such as NIST 927a (ALB, TP), NIST SRM 915 (CA), NIST 911b (CHOL), NIST SRM 917a (GLU), NIST SRM 929 (MG), NIST SRM 3139a (PHOS, PHS, PO4), NIST SRM 912a (UREA, BUN), and NIST SRM 913b (URIC). Lactate and TG/TG-B are traceable to manufacturer's working calibrator. |
| Value Assignment: Values are assigned and stability data is available. | "Value assignment and stability data is available with Beckman Coulter." (Summary statement; specific data not provided in the public summary). The summary states "Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments." |
| Substantial Equivalence: Demonstrate equivalence to the predicate device. | The FDA determined the device is substantially equivalent to the predicate device K883181. This is based on the similarities outlined in the comparison tables and the summary performance data. |
| Inclusion/Exclusion of Analytes: The new calibrator may have a modified panel of value-assigned analytes compared to the predicate, provided equivalence is still shown. | The proposed device includes Lactate and Magnesium as value-assigned analytes, which were not value-assigned in the predicate's intended use. It removes Creatinine. (This difference is acceptable within the context of substantial equivalence if performance is still demonstrated). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a calibrator, "test set" would typically refer to samples analyzed during studies for value assignment, linearity, stability, and comparison to reference materials. The document only states that "Value assignment and stability data is available with Beckman Coulter" and that "Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments." Specific details on sample sizes or data provenance are not public in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable/not provided for a device like a calibrator. Ground truth for a calibrator is established through metrological traceability to reference materials and robust analytical methods, not expert consensus in the same way as, for example, an imaging diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/not provided for this type of device.
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
This is not applicable. This is an in vitro diagnostic calibrator, not a diagnostic imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable in the context of an "algorithm only" performance for this device. Its performance is inherent to its physical and chemical properties and its interaction with the SYNCHRON Systems for calibration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the analytes in the calibrator, the "ground truth" (or reference values) is established through traceability to internationally recognized reference materials, primarily the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRMs), and the manufacturer's working calibrators where NIST SRMs are not directly available (e.g., Lactate, TG, TG-B). This is a metrological ground truth derived from certified reference materials.
8. The sample size for the training set
This is not provided and is generally not applicable for a calibrator in the same way it would be for an AI/ML algorithm. The "training" for a calibrator involves its manufacturing process, value assignment, and stability testing.
9. How the ground truth for the training set was established
Similar to point 7, the "ground truth" for value assignment in the manufacturing and testing of the calibrator is established through metrological traceability to NIST SRMs and manufacturer's working calibrators, following standards like prEN ISO 17511. This involves analytical measurement against higher-order reference materials and/or methods. The specific protocols for this are proprietary to Beckman Coulter but must adhere to regulatory guidelines.
§ 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.