(18 days)
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.
For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of 0,1-antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator Kit 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of cx1-antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents, respectively, with the VITROS 5,1 FS Chemistry Systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
Important Note: The provided text is a 510(k) summary for a calibrator kit and performance verifiers (quality control materials) used in laboratory chemistry systems. These types of devices do not typically involve the same kind of performance studies (e.g., studies with human readers, AI algorithms, or pathology ground truth) as imaging or diagnostic AI/ML devices. The "acceptance criteria" here refer to the device's ability to perform its intended function (calibrating measurements and monitoring performance) in a manner substantially equivalent to a predicate device, rather than diagnostic accuracy against a clinical gold standard.
Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission as the study focuses on analytical performance and equivalence to a predicate, not clinical diagnostic utility in the same way as an AI-powered diagnostic tool.
Acceptance Criteria and Study Details
The submission focuses on demonstrating substantial equivalence of the new Calibrator Kit and Performance Verifiers to previously cleared predicate devices. The "acceptance criteria" are implied by showing that the new devices perform their intended functions (calibrating and monitoring AAT and HPT measurements) effectively and are similar to the predicate devices in formulation and function, with the key difference being the expanded analyte-specific intended use for Haptoglobin (HPT).
1. A table of acceptance criteria and the reported device performance:
Since this is a chemistry calibrator/control device, specific "acceptance criteria" for diagnostic accuracy (sensitivity, specificity, AUC, etc.) are not directly applicable in the same way they would be for an AI diagnostic device. Instead, the "performance" demonstrated is that the new devices function adequately for their intended purpose of calibrating and monitoring measurements on the VITROS 5,1 FS Chemistry Systems.
The acceptance is based on demonstrating the new devices are substantially equivalent to predicate devices. The "performance" is implicitly demonstrated through internal validation studies (not detailed in this summary) that support the expanded intended use and show the materials are suitable for calibrating and monitoring AAT and HPT.
| Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | New device is suitable for calibrating and monitoring both AAT and HPT. | "VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids." and "VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems." (Expanded to include HPT, which is the key change from the predicate). |
| Analytes Covered | Must effectively support measurement of AAT and HPT. | Supports α₁-Antitrypsin (AAT) and Haptoglobin (HPT) analytes. |
| Traceability | Maintain traceable reference material. | Uses the same traceability: BAM-IRMM-LGC ERM-DA470 Reference Material. |
| Number of Levels | Consistent with calibrator/control requirements. | Calibrator Kit: Five levels. Performance Verifiers: Three levels. (Consistent with predicate). |
| Format | Liquid ready to use. | Liquid ready to use. (Consistent with predicate). |
| Fluid Matrix | From processed human serum. | Processed human serum with inorganic salts, buffers, and preservatives. (Consistent with predicate). |
| Overall Safety and Effectiveness | Device is safe and effective for its stated intended uses. | "The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 99 and the VITROS Chemistry Products AAT/HPT Performance Verifiers I, II and III are safe and effective for the stated intended uses." |
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 / Not Provided in Summary: This summary does not contain details about specific "test sets" or clinical data in the way an AI/ML diagnostic would. The evaluation is based on analytical performance and substantial equivalence. For calibrators and controls, this typically involves internal laboratory testing to assign values and ensure stability, linearity, and precision, using methods established by the manufacturer and often following international standards. The specific data (e.g., number of runs, replicates, lots, etc.) that support the performance of the calibrators and verifiers is not detailed in this summary but would have been part of the full 510(k) submission.
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 the context of this device refers to the assigned values of the calibrator and control materials, which are established through a rigorous metrological process, often traceable to international reference materials or methods (as indicated by "BAM-IRMM-LGC ERM-DA470 Reference Material"). This is a technical process, not an expert consensus involving clinical specialists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods are relevant for clinical interpretations, especially in imaging or complex diagnostic scenarios where human interpretation can vary. This is not applicable to an in vitro calibrator or control material.
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 is a calibrator/control device, not an AI or imaging diagnostic device that involves human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a consumable component (calibrator/control) used in an in vitro diagnostic system (VITROS 5,1 FS Chemistry Systems). It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Traceability to Reference Materials: The "ground truth" for the calibrator and control values is established through analytical methods with traceability to internationally recognized reference materials (BAM-IRMM-LGC ERM-DA470 Reference Material). This ensures accuracy and consistency of the assigned values.
8. The sample size for the training set:
- Not Applicable / Not Provided in Summary: This summary does not provide details about a "training set" as it is typically understood for AI/ML algorithms. The development of calibrators and controls involves extensive analytical testing (e.g., stability studies, value assignment studies, matrix equivalency studies, precision studies) but not "training data" in the AI sense.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided in Summary: As above, no "training set" in the AI sense. The ground truth for the analytical parameters (e.g., calibrator values) is established through reference methods and materials.
§ 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.