(56 days)
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
For in vitro diagnostic use only. VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.
These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.
These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.
This is a 510(k) premarket notification for in vitro diagnostic devices, specifically calibrators and controls for chemical analyzers. These types of devices do not typically involve AI components, MRMC studies, or specific performance metrics like sensitivity and specificity measured against a true disease state. Instead, performance is evaluated through analytical studies demonstrating their ability to accurately calibrate and monitor the performance of an assay.
Therefore, many of the requested fields are not applicable to this submission.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the traditional sense for an AI/CADe device (e.g., minimum sensitivity/specificity). Instead, the device's performance is demonstrated through its substantial equivalence to a predicate device and its intended use as a calibrator and control. The primary performance characteristic for these devices is their ability to perform their intended function (calibrate and monitor an assay effectively).
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| VITROS Chemistry Products Calibrator Kit 23 | ||
| Intended Use | Calibrate VITROS 5,1 FS Chemistry Systems for quantitative prealbumin measurement. | Substantially equivalent to predicate, designed for this use. |
| Fluid Matrix | Processed human serum with inorganic salts, buffers, and preservatives. | Device composition matches this description. |
| Analyte Levels | Five levels | Device has five levels. |
| Analyte | Prealbumin (transthyretin) | Device contains prealbumin. |
| Traceability | CRM470 | Device is traceable to CRM470. |
| Format | Liquid ready to use | Device is liquid ready to use. |
| VITROS Chemistry Products PALB Performance Verifiers I and II | ||
| Intended Use | Monitor performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems. | Substantially equivalent to predicate, designed for this use. |
| Fluid Matrix | Processed human serum with inorganic salt, buffers, and preservative. | Device composition matches this description. |
| Analyte Levels | Low and High | Device has low and high levels. |
| Analyte | Prealbumin (transthyretin) | Device contains prealbumin. |
| Format | Liquid ready to use | Device is liquid ready to use. |
Study Proving Acceptance Criteria:
The document focuses on demonstrating substantial equivalence to existing predicate devices (VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, cleared by FDA K041799). This is the key "study" or justification for clearance in this context. The comparison explicitly highlights similarities in intended use (though for different analytes), fluid matrix, format, and traceability.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this type of device. The "test set" in this context would be the internal analytical validation studies performed by the manufacturer to ensure the calibrators and controls function as intended and are stable. These studies typically involve a series of measurements over time and across different instruments. The document does not provide details of such internal studies, which are usually part of the detailed submission reviewed by the FDA but not summarized in the 510(k) summary itself. The provenance of the human serum used is not specified in the 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)
Not applicable. "Ground truth" in this context would relate to the certified values of the calibrator and control materials. This is established through rigorous analytical measurement and traceability to a recognized standard (CRM470), not through expert consensus in a clinical diagnostic sense. Expert medical professionals are not used to establish the "ground truth" for calibrator values.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication is relevant for diagnostic interpretations, not for the analytical performance of calibrators and controls.
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 not an AI/CADe system intended for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these devices is the assigned analyte value (prealbumin level) in each calibrator and control, which is established through:
- Traceability to a recognized reference material: The document states "Traceability: CRM470". CRM470 likely refers to a Certified Reference Material, which provides a highly accurate and precise measurement of the analyte.
- Methodology: Internal validation studies by the manufacturer using established analytical methods.
8. The sample size for the training set
Not applicable. This device does not use machine learning and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable (no training set).
§ 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.