Who is the manufacturer of ROCHE ELECSYS PTH TEST SYSTEM?

Roche Diagnostics Corp. filed the 510(k) submission for ROCHE ELECSYS PTH TEST SYSTEM (K070709).

What is the FDA product code for ROCHE ELECSYS PTH TEST SYSTEM?

CEW. It is classified under 21 CFR 862.1545 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ROCHE ELECSYS PTH TEST SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ROCHE ELECSYS PTH TEST SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ROCHE ELECSYS PTH TEST SYSTEM

K070709 · Roche Diagnostics Corp. · CEW · Jul 13, 2007 · Clinical Chemistry

Device Facts

Record ID	K070709
Device Name	ROCHE ELECSYS PTH TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product Code	CEW · Clinical Chemistry
Decision Date	Jul 13, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1545
Device Class	Class 2

Intended Use

The Elecsys PTH 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. The Elecsys PTH Immunoassay 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. The Elecsys PTH STAT Immunoassay can be used intraoperatively.

Device Story

Two-step sandwich immunoassay using streptavidin microparticles and electrochemiluminescence (ECLIA) detection; measures intact parathyroid hormone (PTH) in human serum/plasma. Used on Elecsys and cobas e immunoassay analyzers in clinical laboratory settings. Input: patient serum/plasma sample. Transformation: automated sandwich formation with labeled antibodies; electrochemiluminescence signal generation proportional to analyte concentration. Output: quantitative PTH concentration (pg/mL). Results interpreted by clinicians alongside medical history and clinical findings to diagnose hypercalcemia/hypocalcemia or monitor intraoperative PTH levels. Benefits: rapid, accurate hormone quantification aiding clinical decision-making.

Clinical Evidence

Clinical evidence provided via three peer-reviewed studies (n=109, n=34, n=153) evaluating intraoperative PTH monitoring during parathyroidectomy. Primary endpoint: >50% decrease in PTH from baseline post-resection. Study 1 (n=109): 107/109 patients showed sufficient decay; 2/2 follow-up surgeries successful. Study 2 (n=34): 34/34 patients showed >50% decrease at 15 minutes. Study 3 (n=153): Mean PTH decay 81% at 15 minutes; assay successfully predicted surgical outcomes in renal hyperparathyroidism patients. Bench testing confirmed hemoglobin interference thresholds.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles. Analyzers: Elecsys 1010, 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601. Measuring range: 1.20–5,000 pg/mL. Standardized against commercial RIA. No specific material standards or software architecture details provided.

Indications for Use

Indicated for in vitro quantitative determination of intact parathyroid hormone in human serum and plasma to aid differential diagnosis of hypercalcemia and hypocalcemia; can be used intraoperatively.

Regulatory Classification

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.

Predicate Devices

Elecsys Parathyroid Hormone Test System (K992680)

Related Devices

K232791 — Access Intact PTH · Beckman Coulter, Inc. · Mar 1, 2024
K070391 — ELECSYS PTH TEST SYSTEM · Roche Diagnostics Corp. · Mar 20, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ JUL 13 2007 #### 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3544 Contact Person: Kay A. Taylor Date Prepared: July 9, 2007 Device Name Proprietary name: Elecsys PTH Immunoassay Elecsys PTH STAT Immunoassay Common name: Parathyroid Hormone Assay Classification name: Radioimmunoassay, Parathyroid Hormone Device The Elecsys PTH and Elecsys PTH STAT Assays are two step sandwich Description 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. Intended The Elecsys PTH Immunoassay is for the in vitro quantitative determination use/Indications of intact parathyroid hormone in human serum and plasma as an aid in the for Use 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. {1}------------------------------------------------ # 510(k) Summary, Continued | Substantial equivalence | The Elecsys PTH and Elecsys PTH STAT Test Systems are substantially equivalent to other devices legally marketed in the United States. The Elecsys PTH and Elecsys PTH STAT Immunoassays (expanded intended use) are equivalent to the Elecsys Parathyroid Hormone Test System (K992680). | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Comparison Table | The following table compares the Elecsys PTH and Elecsys PTH STAT Test Systems and the predicate device. The predicate labeling used as the source document for the comparison is that provided to FDA in K961481/A003. | .. ### Comparison Table | Feature | Predicate Device Elecsys PTH Assay (K992680) | Modified Device Elecsys PTH (18 minute appl.) | Modified Device Elecsys PTH STAT (9 minute appl.) | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indications for Use | 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 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. | | Assay Protocol | Sandwich assay | Same | Same | | Detection Protocol | Electrochemiluminescent Immunoassay | Same | Same | | Feature | Predicate Device Elecsys PTH Assay (K992680) | Modified Device Elecsys PTH (18 minute appl.) | Modified Device Elecsys PTH STAT (9 minute appl.) | | Platform(s) | Elecsys 1010, Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411 and cobas e 601 analyzers. Note: The cobas e analyzers are cleared platforms. Labeling including these analyzers will be manufactured as existing inventories of the product are depleted. | Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411 and cobas e 601 analyzers. | Elecsys 1010, Elecsys 2010 and cobas e 411 | | Total Assay Duration | Elecsys 1010: 9 minute application Elecsys 2010, cobas e 411 MODULAR ANALYTICS E170, and cobas e 601: 18 minute application | 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 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.) | 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 | Unopened: 2-8°C- Up to the stated expiration date Opened: 2-8°C – 12 weeks On Elecsys 2010 and cobas e 411: 8 weeks On 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.) | | Measuring Range | 1.20 – 5,000 pg/mL | Same | Same | | Analytical sensitivity (LDL) | 1.20 pg/mL (0.127 pmol/L) | Same | Same | | Feature | Predicate Device Elecsys PTH Assay (K992680) | Modified Device Elecsys PTH (18 minute appl.) | Modified Device Elecsys PTH STAT (9 minute appl.) | | 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. | Same -- reworded to be more clear No cross-reactivities were found for: Osteocalcin, PTH fragment 1-37, bone-specific alkaline phosphatase, and β- CrossLaps. | | Traceability / Standardization | This method has been standardized against a commercially available PTH test (RIA). | Same -- slightly wording change. This method has been standardized against a commercial PTH test (RIA). | This method has been standardized against Elecsys PTH. 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 | Same | | 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). 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). | 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). 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). | 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). 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). | | Feature | Predicate Device Elecsys PTH Assay (K992680) | Modified Device Elecsys PTH (18 minute appl.) | Modified Device Elecsys PTH STAT (9 minute appl.) | | Precision | Elecsys 1010/ 2010: | Elecsys 2010/cobas e411: | Elecsys 1010: | | | Within-run | Within-run | Within-run | | | Mean | Mean | Mean | | | 5.4% CV @ 30.0 pg/mL | 2.7% CV @ 26.7 pg/mL | 5.4% CV @ 30.0 pg/mL | | | 4.0% CV @ 62.2 pg/mL | 1.6% CV @ 52.5 pg/mL | 4.0% CV @ 62.2 pg/mL | | | 4.0% CV @ 271 pg/mL | 1.5% CV @ 261 pg/mL | 4.0% CV @ 271 pg/mL | | | 5.8% CV @ 44.3 pg/mL | 4.1% CV @ 20.2 pg/mL | 5.8% CV @ 44.3 pg/mL | | | 3.4% CV @ 161 pg/mL | 2.2% CV @ 58.0 pg/mL | 3.4% CV @ 161 pg/mL | | | 3.9% CV @ 702 pg/mL | 1.9% CV @ 676 pg/mL | 3.9% CV @ 702 pg/mL | | | Total | Total | Total | | | Mean | Mean | Mean | | | 5.9% CV @ 30.0 pg/mL | 6.5% CV @ 26.7 pg/mL | 5.9% CV @ 30.0 pg/mL | | | 4.3% CV @ 62.2 pg/mL | 3.9% CV @ 52.5 pg/mL | 4.3% CV @ 62.2 pg/mL | | | 4.3% CV @ 271 pg/mL | 3.0% CV @ 261 pg/mL | 4.3% CV @ 271 pg/mL | | | 7.1% CV @ 44.3 pg/mL | 6.2% CV @ 20.2 pg/mL | 7.1% CV @ 44.3 pg/mL | | | 5.0% CV @ 161 pg/mL | 4.1% CV @ 58.0 pg/mL | 5.0% CV @ 161 pg/mL | | | 5.4% CV @ 702 pg/mL | 2.6% CV @ 676 pg/mL | 5.4% CV @ 702 pg/mL | | | E170: | E170/ cobas e601: | Elecsys 2010/cobas e411: | | | Within-run | Within-run | Within-run | | | Mean | Mean | Mean | | | 2.0% CV @ 25.0 pg/mL | 2.0% CV @ 21.9 pg/mL | 2.1% CV @ 53.4 pg/mL | | | 1.2% CV @ 39.8 pg/mL | 1.2% CV @ 35.0 pg/mL | 1.7% CV @ 215 pg/mL | | | 1.1% CV @ 139 pg/mL | 1.1% CV @ 123 pg/mL | 1.7% CV @ 980 pg/mL | | | 2.2% CV @ 82.2 pg/mL | 2.2% CV @ 72.7 pg/mL | 1.6% CV @ 52.6 pg/mL | |…

ROCHE ELECSYS PTH TEST SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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ROCHE ELECSYS PTH TEST SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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