(28 days)
Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.
The Iron Standard is a single-level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the "Iron Standard" device:
Important Note: The provided document is a 510(k) summary for a calibrator device. Regulatory summaries for calibrators typically focus on demonstrating substantial equivalence to a predicate, not on clinical performance or diagnostic accuracy studies in the same way an AI-powered diagnostic device would. Therefore, many of the requested fields related to clinical studies, human readers, and ground truth in a diagnostic context will not be applicable or explicitly stated.
Acceptance Criteria and Reported Device Performance
The provided document, K052002, is a 510(k) summary for a calibrator. For calibrators, "acceptance criteria" and "device performance" are typically related to their ability to accurately calibrate an assay, their stability, and their comparability to other calibrators. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against predefined acceptance criteria for accuracy or clinical use.
No explicit quantitative acceptance criteria or detailed performance study results (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The "study" here is primarily a substantial equivalence comparison.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document, if applicable) | Reported Device Performance (from document, if applicable) | Notes |
|---|---|---|---|
| Intended Use | Calibration for quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. | Meets this intended use. | Stated in the "Indications for Use" and device description. No performance data beyond "intended use is met" for this. |
| Levels | Not explicitly stated as acceptance criteria, but characteristic is compared. | One level. | Differentiates from predicate (two levels), but implies this is acceptable for its intended purpose. |
| Format | Not explicitly stated as acceptance criteria, but characteristic is compared. | Aqueous solution. | Differentiates from predicate (lyophilized), but implies this is acceptable. |
| Handling | Not explicitly stated as acceptance criteria, but characteristic is compared. | Ready to use. | Differentiates from predicate (requires reconstitution), but implies this is acceptable. |
| Stability | Not explicitly stated as acceptance criteria, but characteristic is compared. | Unopened: 15-25°C until expiration date. | |
| After opening: 15-25°C until expiration date. | Differentiates from predicate (2-8°C unopened, -20°C reconstituted), but implies this is acceptable and verified. | ||
| Matrix | Not explicitly stated as acceptance criteria, but characteristic is compared. | Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. | Compares composition. Implies this is an acceptable and verifiable matrix for a calibrator. |
| Substantial Equivalence | Demonstrated equivalence to predicate Elecsys® C-Peptide Calset (K033873). | Demonstrated through comparison of intended use, levels, format, handling, stability, and matrix, despite differences. | This is the primary "acceptance" for a 510(k) filing. The FDA's letter (K052002) confirms this determination. |
The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, demonstrating substantial equivalence to a legally marketed predicate device. For a diagnostic calibrator, the primary "proof" is the demonstration that it performs its calibration function safely and effectively, and that it is substantially equivalent to existing calibrators on the market. Specific performance data related to its calibration efficacy (e.g., accuracy of calibrated assays) would typically be part of a larger assay's submission, not the calibrator's alone unless novel.
Additional Information Not Applicable or Directly Stated for This Device Type:
Most of the following items are highly relevant for diagnostic devices, especially those utilizing AI, and involve clinical effectiveness studies. As "Iron Standard" is a calibrator, these are generally not applicable and are not found in this 510(k) summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a calibrator, not a diagnostic device undergoing a clinical performance study with a test set of patient data.
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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 for a calibrator relates to its chemical properties and stability, not the interpretation of patient samples by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a calibrator, "ground truth" would relate to the gravimetric preparation and analytical confirmation of the concentration of Ferrous Ammonium Sulfate Hexahydrate, and its stability characteristics. This is a chemical/analytical ground truth, not a clinical one. The document mentions "gravimetrically prepared aqueous solution," which indicates a highly controlled laboratory method for establishing the "truth" of its concentration.
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The sample size for the training set: Not applicable. This is a calibrator; it does not involve machine learning or training sets in the computational sense.
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How the ground truth for the training set was established: Not applicable.
§ 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.