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510(k) Data Aggregation
(281 days)
IDS-iSYS Intact PTHN
The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.
IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.
IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:
- · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
- · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).
The submission is due to a new source of antibody for the assay.
This document describes the performance characteristics of the IDS-iSYS Intact PTHN assay, an in vitro diagnostic device for quantitative determination of intact PTH.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly defined by the reported performance and the comparison to the predicate device. The information below summarizes the performance characteristics provided, which in a regulatory context, demonstrate the device meets its intended use and is substantially equivalent to the predicate.
| Performance Characteristic | Predicate Device (K103325) Performance | Candidate Device (IDS-iSYS Intact PTHN) Performance | Implied Acceptance Criteria (Demonstrated) |
|---|---|---|---|
| Method Comparison (against a commercially available method) | N/A | n=312 samples; Slope: 1.02 (95% CI: 0.99 to 1.04); Intercept: -0.7 pg/mL (95% CI: -5.4 to 4.1); Correlation coefficient (r): 1.00 | Demonstrate strong correlation and agreement with a commercially available quantitative chemiluminescence Intact PTH assay (e.g., r close to 1, slope close to 1, intercept close to 0) as per CLSI EP-9A2 guidelines. |
| Sample Matrix Comparison (vs. K2 EDTA plasma) | N/A | ||
| - Serum (Red Top) | N/A | n=52; Slope: 0.94 (95% CI: 0.92 to 0.97); Intercept: 2.55 (95% CI: 0.86 to 3.16); r: 1.00 | Demonstrate acceptable agreement across different sample matrices (serum, lithium heparin plasma) compared to the control (K2 EDTA plasma) as per CLSI EP9-A3 guidelines. Slopes close to 1 and intercepts close to 0 with good correlation coefficients. |
| - Serum (SST) | N/A | n=52; Slope: 0.93 (95% CI: 0.91 to 0.96); Intercept: 2.38 (95% CI: 1.25 to 3.15); r: 1.00 | |
| - Lithium Heparin | N/A | n=52; Slope: 0.98 (95% CI: 0.95 to 0.99); Intercept: 0.42 (95% CI: -0.43 to 1.63); r: 1.00 | |
| Reference Interval | 11.5 to 78.4 pg/mL | 10.3 to 80.5 pg/mL | Establish a 95% reference interval for a healthy population, consistent with clinical expectations and CLSI C28-A3 guidelines. The new range should be comparable to the predicate. |
| Sensitivity | |||
| - Limit of Blank (LoB) | 1.2 pg/mL | 0.9 pg/mL | Demonstrate low limits of blank, detection, and quantitation, indicating the ability to detect very low concentrations of PTH, as per CLSI EP17-A guidelines. Should be comparable or better than the predicate. |
| - Limit of Detection (LoD) | 2.5 pg/mL | 2.3 pg/mL | |
| - Limit of Quantitation (LoQ) | 4.5 pg/mL | 4.5 pg/mL | |
| Precision | |||
| - Within-run CV% | 1.1% to 6.3% | 1.5% to 9.9% | Demonstrate consistent and reproducible results across different concentration levels, within acceptable ranges for clinical diagnostic assays, as per CLSI EP-5A2 guidelines. Total CV should be within acceptable limits (e.g., |
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(448 days)
IDS-ISYS INTACT PTH
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDSiSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The kit is for in vitro diagnostic use only.
The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay.
The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay.
The IDS-iSYS iPTH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Not Found
This document is a 510(k) clearance letter from the FDA for the IDS-iSYS Intact PTH assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, device performance data, study details, or ground truth information as requested in your prompt.
The FDA 510(k) clearance letter primarily confirms that the device meets the regulatory requirements for marketing based on substantial equivalence. It refers to a "premarket notification" which would typically include the study data, but that specific document is not provided here.
Therefore, I cannot provide the requested table and study details based solely on the provided text. To answer your prompt, you would need the actual premarket notification submission (510(k) documentation) for K103325, which would contain the study results and acceptance criteria.
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