(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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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 Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3544 |
| Contact person: Kay A. Taylor | |
| Date prepared: February 8, 2007 | |
| Device name | |
| Proprietary name: Elecsys PTH ImmunoassayElecsys PTH CalSet | |
| Common name: Parathyroid Hormone AssayCalibrator | |
| Classification name: Radioimmunoassay, Parathyroid HormoneCalibrator, 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. |
.
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| Intended use | (1) Immunoassay is for the in vitro quantitative determination of intactparathyroid hormone in human serum and plasma for the differentialdiagnosis of hypercalcemia and hypocalcemia.(2) Used for calibrating the quantitative Elecsys PTH STAT assay for intactPTH (parathyroid hormone) on the Elecsys and cobas e immunoassayanalyzers. |
|---|---|
| SubstantialEquivalence | The Elecsys PTH STAT Test System (modified) is substantially equivalent toother devices legally marketed in the United States. The Elecsys PTH STATTest System (modified) is equivalent to the Elecsys PTH System (K992680). |
| DeviceComparison | The following table compares the Elecsys PTH STAT Test System (modified)and the predicate device. The predicate labeling used as the source documentfor 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
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| Comparison Table | ||
|---|---|---|
| Feature | Predicate DeviceElecsys PTH Assay | Modified DeviceElecsys PTH STAT9 minute application |
| Assay Protocol | Sandwich assay | Same |
| Detection | Electrochemiluminescent | Same |
| Total AssayDuration | Elecsys 1010: 9 minute applicationElecsys 2010, cobas e 411 E170,and cobas e 601: 18 minuteapplication | 9 minute application only |
| Sample Type | Human serum and plasma treatedwith K3-EDTA. | Same |
| Calibrator | Elecsys PTH CalSet | Elecsys PTH STAT CalSet |
| CalSet Levels | Two | Same |
| MeasuringRange | 1.20 – 5,000 pg/mL | Same |
| Analyticalsensitivity | 1.20 pg/mL(0.127 pmol/L) | Same |
| CalSet Matrix | Human serum w/ synthetic PTH | Same |
| CalSet Storage | Lyophilized | Same |
| CalSet TargetConc. | Cal 1: ~0.05 pg/mLCal 2: ~4500 pg/mL | Same |
| Traceability /Standardization | Standardized against acommercially available PTH test(RIA). | Standardized against Elecsys PTH (Cat.No. 11972103). This in turn wasStandardized against a commercial PTHtest (RIA). |
| Hook Effect | No high dose hook effect at PTHconcentrations up to 17,000 pg/mL. | Same |
| AnalyticalSpecificity | For the monoclonal antibodies used,the following cross-reactivities werefound: Osteocalcin, PTH fragment1-37, bone-specific alkalinephosphatase, and β-Crosslaps: nocross-reactivity detectable. | Same – reworded to be more clearNo cross-reactivities were found for:Osteocalcin, PTH fragment 1-37,bone-specific alkaline phosphatase, andβ-CrossLaps. |
| Comparison Table | ||
| Feature | Predicate DeviceElecsys PTH Assay | Modified DeviceElecsys PTH STAT9 minute application |
| Reagent Stability | Unopened:2-8°C -- Up to the stated expiration dateOpened:2-8°C – 12 weeksOn the E170/cobas e 601 andElecsys 2010/cobas e 411:8 weeksOn the Elecsys 1010:4 weeks (stored alternately in therefrigerator and on the analyzer- ambient temperature 20-25°C; up to 20 hours opened in total.) | SameOpened:2-8°C – 12 weeksOn Elecsys 2010/cobas e 411: 8 weeksOn 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.) |
| CalibrationInterval | 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 |
| CalibrationInterval,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 DeviceElecsys PTH Assay | Modified DeviceElecsys PTH STAT9 minute application |
| Precision | Elecsys 1010/ 2010:Within-run5.4% CV @ 30.0 pg/mL4.0% CV @ 62.2 pg/mL4.0% CV @ 271 pg/mL5.8% CV @ 44.3 pg/mL3.4% CV @ 161 pg/mL3.9% CV @ 702 pg/mLTotal5.9% CV @ 30.0 pg/mL4.3% CV @ 62.2 pg/mL4.3% CV @ 271 pg/mL7.1% CV @ 44.3 pg/mL5.0% CV @ 161 pg/mL5.4% CV @ 702 pg/mLE170:Within-run2.0% CV @ 25.0 pg/mL1.2% CV @ 39.8 pg/mL1.1% CV @ 139 pg/mL2.2% CV @ 82.2 pg/mL2.8% CV @ 265 pg/mL0.6% CV @ 1,215 pg/mLTotal3.4% CV @ 26.4 pg/mL2.5% CV @ 91.5 pg/mL2.8% CV @ 269 pg/mL1.7% CV @ 82.7 pg/mL1.6% CV @ 267 pg/mL1.6% CV @ 1,222 pg/mL | Elecsys 1010:SameSameElecsys 2010/cobas e411Within-run2.1% CV @ 53.4 pg/mL1.7% CV @ 215 pg/mL1.7% CV @ 980 pg/mL1.6% CV @ 52.6 pg/mL2.0% CV @ 182 pg/mL1.8% CV @ 744 pg/mLTotal3.8% CV @ 53.4 pg/mL2.8% CV @ 215 pg/mL2.5% CV @ 980 pg/mL1.9% CV @ 52.6 pg/mL2.5% CV @ 182 pg/mL2.2% CV @ 744 pg/mLE170:Not applicable |
| Feature | Predicate DeviceElecsys PTH Assay | Modified DeviceElecsys PTH STAT9 minute application |
| Limitations | The assay is unaffected by:Icterus (bilirubin <1,112 µmol/L or <65 mg/dL,Hemolysis (Hb < 0.932 mmol/L or < 1.5 g/dL),Lipemia (Intralipid < 1,500 mg/dL)Biotin (<205 nmol/L or < 50 ng/mL)No interference was observed from rheumatoid factors up to a concentration of 1,500 IU/mL In patients receiving therapy with high biotin doses (i.e > 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 < 0.155 mmol/L or < 0.25 g/dL; do not analyze samples that show visible signs of hemolysis) |
| Feature | Predicate DeviceElecsys PTH Assay | Modified DeviceElecsys PTH STAT9 minute application |
| Limitations,continued | As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated 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. The test contains additives which minimize these effects. Extremely high titers of antibodies to streptavidin can occur in isolated cases and cause interference. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical exam and other findings | Same |
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. Ms. Kay Taylor, MT (ASCP), RAC 9115 Hague Road Indianapolis, IN 46250-0457
MAR 2 0 2007
K070391 Trade/Device Name: Elecsys Parathyroid Hormone Test System Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Codes: CEW, JIT Dated: March 05, 2007 Received: March 06, 2007
Dear Ms. Taylor:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070391
Device Name: Elecsys PTH Test System
Indications For Use:
Elecsys PTH Immunoassay (18 minute application) Elecsys PTH STAT Immunoassay (9 minute application)
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 STAT CalSet
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
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
Prescription Use XXXX (Part 21 CFR 801 Subpart D) . AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
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c070391
25
§ 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.