(39 days)
K961481/A003
No
The summary describes a standard immunoassay system and calibration process, with no mention of AI or ML algorithms for data analysis, interpretation, or decision support. The results are determined using a calibration curve and master curve, which are traditional methods.
No
This device is an immunoassay for in vitro quantitative determination of parathyroid hormone, used for differential diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the immunoassay is for the "differential diagnosis of hypercalcemia and hypocalcemia." This indicates its use in identifying or distinguishing diseases or conditions.
No
The device description clearly outlines a two-step sandwich immunoassay utilizing streptavidin microparticles and electrochemiluminescence detection, which are hardware components and chemical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma". The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details an "immunoassay" which is a common type of IVD test. It also mentions using "human serum and plasma" as the sample matrix, which are biological specimens tested in vitro.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K992680 Elecsys PTH System) strongly suggests that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in IVD submissions.
N/A
Intended Use / Indications for Use
(1) 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.
(2) Used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers.
Product codes
CEW, JIT
Device Description
(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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K961481/A003
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K07039/
| 510(k) Summary - Elecsys PTH Test System | |
|---|---|
| -- | ------------------------------------------ |
MAR 2 0 2007
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: February 8, 2007 | |
| Device name | |
| Proprietary name: Elecsys PTH Immunoassay | |
| Elecsys PTH CalSet | |
| Common name: Parathyroid Hormone Assay | |
| Calibrator | |
| Classification name: Radioimmunoassay, Parathyroid Hormone | |
| Calibrator, Secondary | |
| Device description | (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. |
.
1
| Intended use | (1) 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.
(2) Used for calibrating the quantitative Elecsys PTH STAT assay for intact
PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay
analyzers. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Elecsys PTH STAT Test System (modified) is substantially equivalent to
other devices legally marketed in the United States. The Elecsys PTH STAT
Test System (modified) is equivalent to the Elecsys PTH System (K992680). |
| Device
Comparison | The following table compares the Elecsys PTH STAT Test System (modified)
and the predicate device. The predicate labeling used as the source document
for the comparison is from that provided to FDA in K961481/A003. |
Feature Predicate Device Modified Device Elecsys PTH Assay Elecsys PTH STAT 9 minute application Reagent Immunoassay for the in vitro Same Intended quantitative determination of intact Use/Indications parathyroid hormone in human for Use serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. Calibrator Elecsys PTH CalSet is used for Elecsys PTH CalSet STAT is used for Intended Use calibrating the quantitative Elecsys calibrating the quantitative Elecsys PTH PTH assay for intact PTH STAT assay for intact PTH (parathyroid (parathyroid hormone) on the hormone) on the Elecsys and cobas e Elecsys immunoassay analyzers immunoassay analyzers Platform(s) Elecsys 1010, Elecsys 2010, Elecsys 1010, Elecsys 2010, cobas e 411 MODULAR ANALYTICS E170, analyzers cobas e 411 and cobas e 601 analyzers.
Comparison Table
2
| Comparison Table | ||
|---|---|---|
| Feature | Predicate Device | |
| Elecsys PTH Assay | Modified Device | |
| Elecsys PTH STAT | ||
| 9 minute application | ||
| Assay Protocol | Sandwich assay | Same |
| Detection | Electrochemiluminescent | Same |
| Total Assay | ||
| Duration | Elecsys 1010: 9 minute application | |
| Elecsys 2010, cobas e 411 E170, | ||
| and cobas e 601: 18 minute | ||
| application | 9 minute application only | |
| Sample Type | Human serum and plasma treated | |
| with K3-EDTA. | Same | |
| Calibrator | Elecsys PTH CalSet | Elecsys PTH STAT CalSet |
| CalSet Levels | Two | Same |
| Measuring | ||
| Range | 1.20 – 5,000 pg/mL | Same |
| Analytical | ||
| sensitivity | 1.20 pg/mL | |
| (0.127 pmol/L) | Same | |
| CalSet Matrix | Human serum w/ synthetic PTH | Same |
| CalSet Storage | Lyophilized | Same |
| CalSet Target | ||
| Conc. | 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). This in turn was | ||
| Standardized against a commercial PTH | ||
| test (RIA). | ||
| Hook Effect | No high dose hook effect at PTH | |
| concentrations up to 17,000 pg/mL. | Same | |
| Analytical | ||
| Specificity | For the monoclonal antibodies used, | |
| the following cross-reactivities were | ||
| found: Osteocalcin, PTH fragment | ||
| 1-37, bone-specific alkaline | ||
| phosphatase, and β-Crosslaps: no | ||
| cross-reactivity detectable. | Same – reworded to be more clear |
No cross-reactivities were found for:
Osteocalcin, PTH fragment 1-37,
bone-specific alkaline phosphatase, and
β-CrossLaps. |
| Comparison Table | | |
| Feature | Predicate Device
Elecsys PTH Assay | Modified Device
Elecsys PTH STAT
9 minute application |
| Reagent Stability | Unopened:
2-8°C -- Up to the stated expiration date
Opened:
2-8°C – 12 weeks
On the E170/cobas e 601 and
Elecsys 2010/cobas e 411:
8 weeks
On the Elecsys 1010:
4 weeks (stored alternately in the
refrigerator and on the analyzer- ambient temperature 20-25°C; up to 20 hours opened in total.) | Same
Opened:
2-8°C – 12 weeks
On Elecsys 2010/cobas e 411: 8 weeks
On the Elecsys 1010:
4 weeks (stored alternately in the refrigerator and on the analyzer- ambient temperature 20-25°C; up to 20 hours opened in total.) |
| Calibration
Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). | Same |
| Calibration
Interval,
continued | Renewed calibration is recommended as follows:
E170/cobas e 601 and Elecsys 2010/cobas e 411:
After 1 month (28 days) when using the same reagent lot.
After 7 days (when using the same reagent kit on the analyzer).
Elecsys 1010:
With every reagent kit.
After 7 days (20-25°C).
After 3 days (25-32°C). | Elecsys 2010/cobas e 411:
After 1 month (28 days) when using the same reagent lot.
After 7 days (when using the same reagent kit on the analyzer).
Elecsys 1010:
With every reagent kit.
After 7 days (20-25°C).
After 3 days (25-32°C). |
| Feature | Predicate Device
Elecsys PTH Assay | Modified Device
Elecsys PTH STAT
9 minute application |
| Precision | Elecsys 1010/ 2010:
Within-run
5.4% CV @ 30.0 pg/mL
4.0% CV @ 62.2 pg/mL
4.0% CV @ 271 pg/mL
5.8% CV @ 44.3 pg/mL
3.4% CV @ 161 pg/mL
3.9% CV @ 702 pg/mL
Total
5.9% CV @ 30.0 pg/mL
4.3% CV @ 62.2 pg/mL
4.3% CV @ 271 pg/mL
7.1% CV @ 44.3 pg/mL
5.0% CV @ 161 pg/mL
5.4% CV @ 702 pg/mL
E170:
Within-run
2.0% CV @ 25.0 pg/mL
1.2% CV @ 39.8 pg/mL
1.1% CV @ 139 pg/mL
2.2% CV @ 82.2 pg/mL
2.8% CV @ 265 pg/mL
0.6% CV @ 1,215 pg/mL
Total
3.4% CV @ 26.4 pg/mL
2.5% CV @ 91.5 pg/mL
2.8% CV @ 269 pg/mL
1.7% CV @ 82.7 pg/mL
1.6% CV @ 267 pg/mL
1.6% CV @ 1,222 pg/mL | Elecsys 1010:
Same
Same
Elecsys 2010/cobas e411
Within-run
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
Total
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
E170:
Not applicable |
| Feature | Predicate Device
Elecsys PTH Assay | Modified Device
Elecsys PTH STAT
9 minute application |
| Limitations | The assay is unaffected by:
Icterus (bilirubin 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration In vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been tested with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. | Same except,
Hemolysis (Hb