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510(k) Data Aggregation
(121 days)
ROCHE ELECSYS PTH TEST SYSTEM
The Elecsys PTH Immunoassay is for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The Elecsys PTH STAT Immunoassay is for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys PTH and Elecsys PTH STAT Assays are 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.
The provided text details a 510(k) summary for the "Elecsys PTH Immunoassay" and "Elecsys PTH STAT Immunoassay" devices, seeking to demonstrate substantial equivalence to a predicate device (Elecsys PTH Assay, K992680). The information mainly focuses on comparing the features and performance of the modified devices against the predicate, particularly in terms of assay duration, platforms, and analytical performance characteristics like precision.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a go/no-go format for external validation. Instead, it presents a comparison of the modified devices' performance characteristics against those of the predicate device (Elecsys PTH Assay, K992680), implying that performance similar to or improved over the predicate is acceptable. The detailed aspects compared are:
| Feature | Predicate Device (Elecsys PTH Assay, K992680) | Modified Device (Elecsys PTH 18 min appl.) | Modified Device (Elecsys PTH STAT 9 min appl.) |
|---|---|---|---|
| Intended Use/Indications | In vitro quantitative determination of intact PTH in human serum and plasma for differential diagnosis of hypercalcemia and hypocalcemia. | Same, plus "can be used intraoperatively." | Same, plus "can be used intraoperatively." |
| Assay Protocol | Sandwich assay | Same | Same |
| Detection Protocol | Electrochemiluminescent Immunoassay | Same | Same |
| Platform(s) | Elecsys 1010, Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. | Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. | Elecsys 1010, Elecsys 2010, cobas e 411. |
| Total Assay Duration | Elecsys 1010: 9 min; Others: 18 min | 18 minute | 9 minute |
| Sample Type | Human serum and plasma treated with K3-EDTA. | Same | Same |
| Calibrator | Elecsys PTH CalSet | Same | Elecsys PTH STAT CalSet |
| Reagent Stability | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform, with 1010 having specific ambient temp/duration limits) | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform) | Unopened: 2-8°C (up to expiration date); Opened: 2-8°C (8-12 weeks depending on platform, with 1010 having specific ambient temp/duration limits) |
| Measuring Range | 1.20 – 5,000 pg/mL | Same | Same |
| Analytical sensitivity (LDL) | 1.20 pg/mL (0.127 pmol/L) | Same | Same |
| Analytical Specificity | No cross-reactivity with Osteocalcin, PTH 1-37, bone-specific alkaline phosphatase, β-Crosslaps. | Same (reworded for clarity) | Same (reworded for clarity) |
| Traceability/Standardization | Standardized against a commercial PTH test (RIA). | Same (slight wording change) | Standardized against Elecsys PTH, which was standardized against a commercial PTH test (RIA). |
| Hook Effect | No high dose hook effect up to 17,000 pg/mL. | Same | Same |
| Calibration Interval | Once per reagent lot (fresh reagent). Renewed calibration after 1 month/7 days depending on platform. | Same | Same |
| Precision (Within-run CV) | Elecsys 1010/2010: 4.0-5.8% (30-271 pg/mL); E170: 1.1-2.8% (25-1215 pg/mL) | Elecsys 2010/cobas e411: 1.5-4.1% (20.2-676 pg/mL); E170/cobas e601: 0.6-2.8% (21.9-1092 pg/mL) | Elecsys 1010: 3.4-5.8% (30-702 pg/mL); Elecsys 2010/cobas e411: 1.6-2.1% (52.6-980 pg/mL) |
| Precision (Total CV) | Elecsys 1010/2010: 4.3-7.1% (30-702 pg/mL); E170: 1.6-3.4% (26.4-1222 pg/mL) | Elecsys 2010/cobas e411: 2.6-6.5% (20.2-676 pg/mL); E170/cobas e601: 1.6-3.4% (23.2-1098 pg/mL) | Elecsys 1010: 4.3-7.1% (30-702 pg/mL); Elecsys 2010/cobas e411: 1.9-3.8% (52.6-980 pg/mL) |
| Limitations (Hemolysis) | Unaffected by Hb |
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(39 days)
ELECSYS PTH TEST SYSTEM
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 |
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