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510(k) Data Aggregation
(39 days)
Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PTH CalSet STAT is used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers. Elecsys PTH CalSet is used for calibrating the quantitative Elecsys PTH assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers
(1) The Elecsys PTH STAT Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys PTH STAT CalSet is a lyophilized product consisting of human serum with added synthetic PTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The Elecsys PTH Test System is an immunoassay device for the quantitative determination of intact parathyroid hormone in human serum and plasma, used for the differential diagnosis of hypercalcemia and hypocalcemia. The information provided outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence, rather than detailing a study focused on acceptance criteria. Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted directly from the provided text for this device.
However, based on the comparison provided, we can infer some performance characteristics that serve as "acceptance criteria" through comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria (as implied by predicate comparison) | Predicate Device (Elecsys PTH Assay) Performance | Modified Device (Elecsys PTH STAT) Performance |
|---|---|---|
| Intended Use | Immunoassay for in vitro quantitative determination of intact PTH in human serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia. | Same |
| Assay Protocol | Sandwich assay | Same |
| Detection Method | Electrochemiluminescent | Same |
| Sample Type | Human serum and plasma treated with K3-EDTA | Same |
| Calibrator Name | Elecsys PTH CalSet | Elecsys PTH STAT CalSet |
| Calibrator Levels | Two | Same |
| Measuring Range | 1.20 – 5,000 pg/mL | Same |
| Analytical Sensitivity | 1.20 pg/mL (0.127 pmol/L) | Same |
| Calibrator Matrix | Human serum w/ synthetic PTH | Same |
| Calibrator Storage | Lyophilized | Same |
| Calibrator Target Concentrations | Cal 1: ~0.05 pg/mL, Cal 2: ~4500 pg/mL | Same |
| Traceability/Standardization | Standardized against a commercially available PTH test (RIA). | Standardized against Elecsys PTH (Cat. No. 11972103), which was standardized against a commercial PTH test (RIA). |
| Hook Effect | No high dose hook effect up to 17,000 pg/mL | Same |
| Analytical Specificity | No cross-reactivity with Osteocalcin, PTH fragment 1-37, bone-specific alkaline phosphatase, and β-Crosslaps. | Same (reworded for clarity) |
| Opened Reagent Stability (Elecsys 2010/cobas e 411) | 8 weeks | 8 weeks |
| Opened Reagent Stability (Elecsys 1010) | 4 weeks | 4 weeks |
| Calibration Interval (same reagent lot, Elecsys 2010/cobas e 411) | After 1 month (28 days) | After 1 month (28 days) |
| Calibration Interval (same reagent kit, Elecsys 2010/cobas e 411) | After 7 days | After 7 days |
| Calibration Interval (Elecsys 1010) | With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C) | With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C) |
| Precision (Within-run, Elecsys 2010/cobas e411) | N/A (different values reported for predicate. See below for relevant predicate precision values) | 2.1% CV @ 53.4 pg/mL, 1.7% CV @ 215 pg/mL, 1.7% CV @ 980 pg/mL, 1.6% CV @ 52.6 pg/mL, 2.0% CV @ 182 pg/mL, 1.8% CV @ 744 pg/mL |
| Precision (Total, Elecsys 2010/cobas e411) | N/A (different values reported for predicate. See below for relevant predicate precision values) | 3.8% CV @ 53.4 pg/mL, 2.8% CV @ 215 pg/mL, 2.5% CV @ 980 pg/mL, 1.9% CV @ 52.6 pg/mL, 2.5% CV @ 182 pg/mL, 2.2% CV @ 744 pg/mL |
| Limitations (Hemolysis) | Hemolysis (Hb < 0.932 mmol/L or < 1.5 g/dL) | Hemolysis (Hb < 0.155 mmol/L or < 0.25 g/dL; do not analyze samples that show visible signs of hemolysis) |
| Total Assay Duration (Elecsys 1010 platform) | 9 minute application | 9 minute application only |
| Total Assay Duration (Elecsys 2010, cobas e 411, E170, cobas e 601 platform) | 18 minute application | 9 minute application only (for the modified device on platforms other than Elecsys 1010) |
The study that proves the device meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device (Elecsys PTH System K992680, and further comparison to K961481/A003 for predicate labeling). The modified device, Elecsys PTH STAT Test System, is deemed substantially equivalent because its fundamental technology, intended use, and performance characteristics are either identical or demonstrably as safe and effective as the predicate. The changes primarily relate to a "9 minute application" for the Elecsys PTH STAT compared to an 18-minute application for some predicate device platforms (Elecsys 2010, cobas e 411 E170, and cobas e 601), and a tighter hemolysis limitation. The precision data for the Elecsys 2010/cobas e411 platform is different than the predicate, but this is presented as a characteristic of the modified device rather than a criteria to be met against a specific number from the predicate.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly mentioned in the provided text.
- Data Provenance: Not explicitly mentioned (e.g., country of origin, retrospective/prospective). The document describes a comparison to a predicate device and lists performance characteristics, but does not detail the specific studies (number of samples, study design) that generated the data for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This is a quantitative immunoassay device, and "ground truth" for its performance would typically be established through analytical validation studies (e.g., comparison to reference methods, spike-and-recovery, linearity studies) rather than expert consensus on diagnostic images or clinical assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. As above, this type of adjudication is not typically used for analytical validation of quantitative immunoassay devices.
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 not an AI-assisted diagnostic imaging device that requires human interpretation; it is a laboratory immunoassay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Elecsys PTH STAT Immunoassay is a standalone laboratory assay. Its performance characteristics (precision, analytical sensitivity, measuring range, etc.) are determined directly by the automated analytical system without human interpretive input for the final test result. The data presented in the comparison table reflects this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For an immunoassay, the "ground truth" for its analytical performance is typically established against reference methods, certified reference materials, and validated analytical techniques. For example, analytical sensitivity and measuring range are determined by established laboratory procedures using known concentrations of the analyte. Traceability is established against commercial PTH tests (RIA), indicating a comparison to existing, accepted methods for PTH measurement.
8. The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on biochemical reactions and instrument calibration.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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