← Product Code [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW) · K992680 # ELECSYS PARATHYROID HORMONE TEST SYSTEM (K992680) _Roche Diagnostics Corp. · CEW · Sep 28, 1999 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW/K992680 ## Device Facts - **Applicant:** Roche Diagnostics Corp. - **Product Code:** [CEW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEW.md) - **Decision Date:** Sep 28, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1545 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. ## Device Story The ELECSYS® Parathyroid Hormone Test System is an in vitro diagnostic immunoassay used for the quantitative measurement of parathyroid hormone (PTH) in human serum and plasma. The device utilizes a two-step sandwich immunoassay principle incorporating streptavidin-coated microparticles and electrochemiluminescence detection. It is designed for use on ELECSYS® 2010 and 1010 immunoassay analyzers. The system generates results using a 2-point calibration curve and a master curve provided via reagent bar code. The device is intended for use by clinical laboratory professionals to aid in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. By providing accurate PTH levels, the system assists clinicians in evaluating parathyroid function and managing patients with abnormal calcium levels. ## Clinical Evidence Bench testing only. Performance characteristics compared to the predicate include within-run precision (3.4%–5.8% CV), total precision (4.3%–7.1% CV), and analytical sensitivity (1.20 pg/mL). Interference studies confirmed no significant impact from bilirubin, hemoglobin, intralipid, biotin, or rheumatoid factor at specified concentrations. No high-dose hook effect observed up to 17,000 U/mL. ## Technological Characteristics Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin microparticles. Analyzers: ELECSYS® 2010 and 1010. Measuring range: 1.20-5000 pg/mL. Calibration: 2-point calibration with master curve via bar code. Connectivity: Integrated with ELECSYS® analyzers. ## Regulatory 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 - Nichols Intact Parathyroid Hormone (PTH) Immunoassay ([K954418](/device/K954418.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ : : # 510(k) Summary | 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 Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 576 3723 | | | Contact person: Priscilla A Hamill | | | Date prepared: August 9, 1999 | | Predicate device | The ELECSYS® Parathyroid Hormone Test System is equivalent to other devices legally marketed in the United States. We claim equivalence to the Nichols RIA test for Parathyroid Hormone (K954418). | | Device Name | Proprietary name: ELECSYS® Parathyroid Hormone Test System | | | Common name: Parathyroid Hormone Test | | | Classification name: Radioimmunoassay, Parathyroid Hormone | | Device description | The ELECSYS® Parathyroid Hormone Test System is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. | | | Results are determined usin 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. | {1}------------------------------------------------ : | Intended use | For the quantitative determination of parathyroid hormone in human serum
and plasma. | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for
use | For differential diagnosis of hypercalcemia and hypocalcemia. | | Substantial
equivalence | The ELECSYS® Parathyroid Hormone Test System is equivalent to other
devices legally marketed in the United States. We claim equivalence to the
Nichols Intact Parathyroid Hormone (PTH) Immunoassay (K954418). | | Substantial
equivalence -
similarities | The following table compares the ELECSYS® Parathyroid Hormone Test
System, with the predicate device. | | Feature | ELECSYS® Parathyroid
Hormone Test System | Predicate Device | |--------------------|---------------------------------------------------------------------|-----------------------------------------------------------------| | Intended use | for the quantitative
determination of
parathyroid hormone | for the quantitative
determination of
parathyroid hormone | | Indication for use | For differential diagnosis of
hypercalcemia and
hypocalcemia. | An aid in the assessment of
calcium metabolism
disorders. | | Sample type | Human serum and plasma | Human serum and plasma | : {2}------------------------------------------------ Substantial equivalence differences The following table compares the ELECSYS® Parathyroid Hormone Test System, with the predicate device. | Feature | ELECSYS® Parathyroid
Hormone Test System | Predicate Device | |---------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Assay principle | Electrochemiluminescence
immunoassay employing
the sandwich principle. | Two-site
immunoradiometric assay
(IRMA) | | Instrument | ELECSYS® 2010 and 1010
Immunassay analyzers | Gamma counter | | Measuring range | 1.20-5000 pg/mL (0.127-
530 pmol/L) | 1.0pg/mL-highest calibrator | | Expected values | 15-65 pg/mL (1.6-6.9
pmol/L) | 10-65 pg/mL | | Traceability | Traceable to a
commercially available RIA
PTH test | No information in package
insert | | Analytical
specificity | No detection of β -
CrossLaps, osteocalcin,
Human PTH-fragment 1-37
and bone-specific alkaline
phosphatase; | No detection of Human
PTH fragments 1-34, 39-68,
53-84, 44-68, and 39-84 | {3}------------------------------------------------ Substantial equivalence performance characteristics The performance characteristics of the ELECSYS® Parathyroid Hormone Test System and the predicate device are compared in the table below. | Feature | ELECSYS® Parathyroid
Hormone Test System | Predicate Device | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | Within-Run
precision (%CV) | 5.4% at 30.0 pg/mL
4.0% at 62.2 pg/mL
4.0% at 271 pg/mL
5.8% at 44.3 pg/mL
3.4% at 161 pg/mL
3.9% at 702 pg/mL | 3.4% at 40 pg/mL
1.8% at 266 pg/mL | | Total precision
(%CV) | 5.9% at 30.0 pg/mL
4.3% at 62.2 pg/mL
4.3% at 271 pg/mL
7.1% at 44.3 pg/mL
5.0% at 161 pg/mL
5.4% at 702 pg/mL | 6.6% at 38 pg/mL
6.1% at 277 pg/mL | | Analytical
sensitivity | 1.20 pg/mL | 1 pg/mL | {4}------------------------------------------------ Substantial equivalence performance characteristics, continued The performance characteristics of the ELECSYS® Parathyroid Hormone Test System and the predicate device are compared in the table below. | Feature | ELECSYS® Parathyroid
Hormone Test System | Predicate Device | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | Limitations | No interference from
bilirubin up to 65 mg/dL No interference from
hemoglobin up to 1.5 g/dL No interference from
intralipid up to 1500
mg/dL No interference from
biotin up to 50 ng/mL No interference from
rheumatoid factor up to
1500 U/mL No high dose hook effect
up to 17,000 U/mL | No high dose hook effect
up to 100,000 pg/mL | | Open vial
stability | Open vial - 12 weeks (2-8° C) | Reconstituted - 6 weeks
(2-8° C) | | On-board
stability | ELECSYS® 2010: 8 weeks
ELECSYS® 1010: 4 weeks
(stored alternately in
refrigerator and analyzer at
ambient temperature 20-25 C)
Up to 20 hr. opened in total | NA | | Calibration
frequency | ELECSYS® 2010:
After 1 month (same lot) after 7 days - same kit ELECSYS® 1010 with every reagent kit after 7 days (20-25° C) after 3 days (25-32° C) | Assay calibrators with
each run | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people or a family. The figures are depicted in a flowing, interconnected manner. SEP 2 8 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 Re: K992680 > Trade Name: ELECSYS® Parathyroid Hormone Test System Regulatory Class: II Product Code: CEW Dated: August 9, 1999 Received: August 10, 1999 Dear Ms. Hamill: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ #### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Sutman Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT 510(k) Number (if known):-NHA- K992680 Device Name: ELECSYS® Parathyroid Hormone Test System Indications For Use: For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. San Cooper (Division Sign Off) Division of Clinical Laboratory Devices 1.80 K Upg 51 k) Number . (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use
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