(47 days)
UCAL (Urine Protein Calibrator), when used in conjunction with Beckman microalbumin (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and unine immunoglobulin G (IGU) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
The Beckman Urine Protein Calibrator is prepared from human urine to which albumin, transferrin, alpha-1-microglobulin, and immunoglobulin G have been added. Assay of UCAL provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which MA, TRU, A1M, and IGU concentration values are determined for test specimens.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Beckman Urine Protein Calibrator (UCAL).
Based on the provided K973928 document, the submission is for a Calibrator for in vitro diagnostic use. The purpose of a calibrator is to establish reference points for measuring substances. Therefore, the "device performance" in this context refers to the calibrator's ability to consistently and accurately provide values for calibration.
Critical Note: This document does not contain detailed information about specific numerical acceptance criteria or a formal clinical/analytical study designed to prove the device meets such criteria in the way a medical device efficacy study typically would. This K973928 is a 510(k) premarket notification for a calibrator, which often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed statistical metrics, particularly for performance metrics like sensitivity, specificity, accuracy, etc., which are common for diagnostic tests.
Instead, the document emphasizes the value assignment and verification process for the calibrator, ensuring it performs comparably to the predicate device and across different instrumentation.
1. Table of Acceptance Criteria and Reported Device Performance
As detailed acceptance criteria with quantitative targets (e.g., "accuracy > 95%") are not explicitly stated in this 510(k) summary, I will infer what "acceptance" means in the context of a calibrator and the information provided.
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| A. Substantial Equivalence to Predicate Device | The device is "identical to the current product" except for an additional instrument platform. "Summary of Performance Data" states that safety and effectiveness support "substantial equivalence to chemistry test systems already in commercial distribution." This implies the performance is accepted if it matches the predicate. |
| B. Consistent Value Assignment | "The value assignment process for each analyte is correlated to a known standard via the anchor method." |
| C. Acceptable Calibrator Assigned Values for Calibration Systems | "The Beckman Urine Protein Calibrator value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems." (No specific numerical range or threshold is provided, but the process is deemed "acceptable.") |
| D. Functional on Specified Instrument Platforms | Designed for use on Array®, Array® 360, and IMMAGE™ Systems. The document explicitly includes the IMMAGE™ system as a new platform for this calibrator, suggesting performance on this system was evaluated. |
| E. Retention of Intended Use | The intended use clearly specifies its role as a calibrator for MA, TRU, A1M, and IGU reagents on the specified systems. The submission confirms this intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document. For a calibrator, a "test set" might refer to multiple lots of the calibrator being manufactured and tested, or repetitions of measurements on control materials.
- Data Provenance: Not specified (e.g., country of origin). The study appears to be an internal performance evaluation by Beckman Instruments, Inc.
- Retrospective or Prospective: Not specified, but likely part of a prospective manufacturing and validation process for the calibrator lots and its use on the new IMMAGE™ system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of information (number and qualifications of experts) is typically associated with studies involving human observation, interpretation (like radiology or pathology), or complex diagnostic tasks. For a calibrator, the "ground truth" is generally established through a traceability chain to reference materials and established analytical methods.
- Number of Experts: Not applicable/not stated.
- Qualifications of Experts: Not applicable/not stated. The ground truth likely comes from certified reference materials and the expertise of analytical chemists/engineers within Beckman.
4. Adjudication Method for the Test Set
Not applicable/not stated. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or experts when establishing a consensus ground truth, which is not relevant for calibrator value assignment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study focuses on how human readers perform with or without AI assistance, which is irrelevant for a calibrator.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Yes, in spirit, a standalone evaluation was done. The "device" here is the calibrator itself, and its performance (value assignment and verification) is assessed independently of a human interpreter. The calibrator's assigned values are determined and then verified by instruments/analytical methods. While humans are involved in the process of value assignment and verification, the "performance" of the calibrator in setting reference points is an inherent property of the material itself and how it interacts with the instrument, which is then analytically confirmed.
7. The Type of Ground Truth Used
- Established Reference Standards/Traceability: The document states, "The value assignment process for each analyte is correlated to a known standard via the anchor method." This indicates that the ground truth for the calibrator's assigned values is based on traceability to known analytical standards. For diagnostic calibrators, this typically means:
- Certified Reference Materials (CRMs): Materials with precisely known concentrations of analytes, usually traceable to international standards (e.g., NIST).
- Validated Analytical Methods: Highly accurate and precise laboratory methods used to determine the exact concentration of analytes in the calibrator material, linked to primary reference measurement procedures.
8. The Sample Size for the Training Set
- Not applicable/not stated. Calibrators, in this context, are not "trained" in the way an AI algorithm or machine learning model would be. Their values are assigned and verified through analytical processes, not through learning from a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable/not stated. As there is no "training set" in the machine learning sense for a calibrator, this question does not apply. The ground truth for the calibrator's assigned values is established through correlation to known standards via the anchor method, as explained in point 7.
§ 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.