(49 days)
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No
The description details a standard immunoassay based on electrochemiluminescence detection and calibration curves, with no mention of AI or ML terms or functionalities.
No
This device is for in vitro quantitative determination of a hormone, used for diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the device is for the "differential diagnosis of hypercalcemia and hypocalcemia."
No
The device description clearly states it is a "Test System" based on a "two step sandwich immunoassay with 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 "For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma". The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Device Description: The description mentions using "human serum and plasma" as the sample type, which are biological specimens commonly used in IVD testing.
- Assay Type: The description details a "two step sandwich immunoassay," which is a common type of assay used in IVD tests to measure specific substances in biological samples.
N/A
Intended Use / 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.
Product codes
CEW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the ELECSYS® Parathyroid Hormone Test System and the predicate device are compared in the table below.
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
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
Analytical sensitivity: 1.20 pg/mL
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
Open vial stability: Open vial - 12 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
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: 1.20 pg/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
:
:
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-
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
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-