(121 days)
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 |
§ 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.