(70 days)
The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage Specialty System for the quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Nichols Advantage Intact PTH assay contains sufficient reagents for 100 tests. The assay is a two-site chemiluminometric assay specific for Intact PTH.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone device:
Based on the provided 510(k) summary, the device is an immunoassay for quantitative determination of intact parathyroid hormone (PTH). The primary purpose of this type of submission (510(k)) is to demonstrate substantial equivalence to a predicate device, rather than to establish a new clinical utility or performance against fixed acceptance criteria in a novel clinical study.
The "acceptance criteria" in this context are not defined as specific performance thresholds (e.g., sensitivity, specificity, accuracy) against a clinical gold standard, but rather relate to the demonstration that the modified device performs similarly to or better than the predicate device, and that the modifications do not introduce new safety or effectiveness concerns.
The summary states: "The device with modified labeling is substantially equivalent to the predicate device."
Here's a breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
Given the nature of a 510(k) for an immunoassay where the core technology is unchanged and the focus is on demonstrating equivalence after minor modifications, the "acceptance criteria" are implied comparisons to the predicate device's established performance or confirmation of expected analytical characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device for new specimen matrix: Expanded specimen types (heparinized plasma) should yield results essentially equivalent to those obtained with existing accepted specimen types (serum, EDTA plasma) or the predicate device. | - Heparinized plasma was added to the specimen matrix for Intact PTH testing. |
| Compatibility with Blood Collection Tubes: Use of different blood collection tubes should not significantly impact results. | - Use of 6 different blood collection tubes was compared for similarities and differences for Intact PTH testing, and results of comparative testing yield essentially equivalent results. |
| Specimen Stability: New specimen types (EDTA plasma, heparinized plasma) and serum should have established stability data. | - Specimen stabilities have been included in the new labeling for EDTA plasma, Heparinized plasma, and serum testing. (The document doesn't provide the duration of stability, just that it's included in labeling). |
| Clinical Utility Justification: Updated labeling for use in chronic kidney disease patients should be supported by scientific references. | - New labeling and scientific references supporting use of Intact PTH testing in patients with chronic kidney diseases were added. (The document doesn't list the references, only states they were added). |
| Cross-reactivity: The assay should be specific for intact PTH and not cross-react significantly with related substances like PTH fragments or PTHrP. | - Crossreactivity to human PTH 7-84 was determined to be equimolar in the assay. (This means it reacts equally with this fragment, which is relevant as PTH 7-84 is a known fragment. It doesn't state if this is ideal or a limitation, but it's a measured characteristic). |
- Crossreactivity to human PTHrP 1-40 was determined to not cross react in the assay. (This indicates good specificity against PTHrP). |
| No Change in Technology: The core assay methodology should remain consistent with the predicate device. | - There is no change in technology from the original device cleared under K962598. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes
for the studies conducted. It only generally describes the types of comparisons made (e.g., 6 different blood collection tubes).
Data provenance (e.g., country of origin, retrospective/prospective) is also not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable to an immunoassay 510(k) submission focused on analytical performance and substantial equivalence. Ground truth for an immunoassay is typically established via reference methods or clinical samples with confirmed conditions, not expert consensus on image interpretation. The document does not mention any expert review or qualification for establishing "ground truth."
4. Adjudication method for the test set
Not applicable, as there's no mention of expert review or adjudication.
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 to an immunoassay for quantitative measurement of a biomarker. MRMC studies are relevant for imaging devices or AI tools that assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an immunoassay, which is a standalone diagnostic test performed in a lab, generating a numerical result. It doesn't involve an "algorithm only" component in the sense an AI diagnostic tool would, nor does it typically involve a "human-in-the-loop" for interpreting its direct output in the same way an imaging AI would. The human (clinician) interprets the results of the test in conjunction with other clinical data.
7. The type of ground truth used
For an immunoassay, "ground truth" for demonstrating analytical performance typically involves:
- Reference standards/calibrators: For accuracy, linearity, and precision.
- Spiked samples: To assess recovery and interference.
- Clinical samples with established diagnoses: To assess clinical performance (though this document focuses on analytical equivalence, not a new clinical claim).
The document details analytical comparisons, but does not explicitly state the "ground truth" methodology for specific analytical parameters. For cross-reactivity, it appears to use purified substances (human PTH 7-84, human PTHrP 1-40). For blood tube comparisons and specimen stability, the ground truth would be the results obtained from a reference or established method/tube, against which others are compared.
8. The sample size for the training set
This is not applicable to an immunoassay device, which is not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.