Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay technology and does not mention any AI or ML components. The results are determined using a calibration curve, which is a traditional method.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of parathyroid hormone, used as an aid in diagnosis, not for direct treatment or therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the device is "as an aid in the differential diagnosis of hypercalcemia and hypocalcemia." This explicitly mentions diagnosis as its purpose.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic immunoassay kit, which includes reagents and is intended for use on specific hardware analyzers. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Elecsys PTH Immunoassay is "for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma". The term "in vitro" is a key indicator of an IVD.
Device Description: The description details an "electrochemiluminescence immunoassay 'ECLIA'", which is a laboratory-based test performed on biological samples (serum and plasma).
Sample Type: The test is performed on "human serum and plasma", which are biological samples.
Purpose: The test is used as "an aid in the differential diagnosis of hypercalcemia and hypocalcemia", which is a diagnostic purpose.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

Product codes (comma separated list FDA assigned to the subject device)

CEW

Device Description

The Elecsys PTH and Elecsys PTH STAT Assays are 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.

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

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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): 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.

K992680

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 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.

Summary

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).

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 3 2007

Roche Diagnostics Corp. c/o Ms. Kay Taylor Regulatory Affairs Principal 9115 Hague Road P.O. Box 50457 Indianaoplis, IN 46250-0457

Re: K070709

Trade/Device Name: Elecsys PTH Immunoassay and Elecsys PTH STAT Immunoassay Regulation Number: 21 CFR $862.1545 Regulation Name: Parathyroid hormone test system. Regulatory Class: Class II Product Code: CEW Dated: June 18, 2007 Received: June 20, 2007

Dear Ms. Taylor:

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).

8

Page 2 -

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.

Sean 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

9

Indication for Use

510(k) Number (if known): K070709

Device Name: Elecsys PTH Immunoassay and Elecsys PTH STAT Immunoassay

Indication For Use:

Elecsys PTH Immunoassay:

The Elecsys PTH: 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 assay can be used intraoperatively.

Elecsys PTH STAT Immunoassay:

The Elecsys PTH STAT: 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 STAT assay can be used intraoperatively.

Prescription Use XXXX (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benem

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070709