The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

Device Description

The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.

AI/ML Overview

The provided text describes the ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay, a device intended for the quantitative determination of iPTH in EDTA plasma or serum to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism. The document focuses on demonstrating the substantial equivalence of a modified version of this assay to its predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table for each performance characteristic with pass/fail outcomes. Instead, it describes various performance studies and presents their results, implying that these results met internal criteria for demonstrating substantial equivalence. Based on the described tests, here's a reconstructed table of implicit acceptance criteria and the reported performance:

Performance Characteristic	Implicit Acceptance Criteria (based on study design and intent)	Reported Device Performance
Precision	CVs within acceptable clinical limits; comparable to predicate.	Pool 1: 16.1 pg/mL, 7.7% Total CV Control 1: 38.7 pg/mL, 4.7% Total CV Pool 2: 62.8 pg/mL, 3.7% Total CV Control 2: 185 pg/mL, 3.2% Total CV Control 3: 663 pg/mL, 2.8% Total CV Pool 3: 839 pg/mL, 3.9% Total CV Pool 4: 1698 pg/mL, 3.2% Total CV
Detection Limits (LoB, LoD, LoQ)	LoB, LoD, LoQ established and clinically acceptable. Compare favorably to predicate (implied, though not directly shown).	LoB: 0.1 pg/mL LoD: 2.7 pg/mL LoQ: 6.3 pg/mL
Linearity / Assay Range	Linear response across the claimed assay range.	Regression: y = 0.98x - 4.98, R = 1.00 Assayed range: 4.4 to 2021 pg/mL (claimed range 6.3 - 1900 pg/mL)
High Dose Hook Effect	No high dose hook effect observed.	No high dose hook was observed for either reagent lot (tested up to 144,000 pg/mL).
Interfering Substances	Bias ≤ 10% effect at specified interferent levels.	Hemoglobin (500mg/dL): 4% and -1% bias Triglycerides (3000mg/dL): 7% and -4% bias Conjugated Bilirubin (40mg/dL): 7% and 0% bias Unconjugated Bilirubin (40mg/dL): 7% and 8% bias Biotin (1000ng/mL): 8% and 6% bias
Cross-reacting Substances	Low to no cross-reactivity with related substances, except for clinically expected interactions.	PTH 7-84: ~51% cross-reactivity (noted as an exception, implying this level is understood or acceptable) All other listed cross-reactants (PTH 1-34, 39-68, 39-84, 44-68, 53-84, Calcitonin, Beta-Cross Laps, Osteocalcin): showed 0.0% to 0.2% cross-reactivity (very low).
Method Comparison	Good correlation with the predicate device (R-value close to 1, slope near 1, intercept near 0).	EDTA Plasma: y = 0.98x + 10.6, R = 1.00 (N=106, range 11.8 - 1862 pg/mL) Serum: y = 1.00x + 5.0, R = 1.00 (N=105, range 9.8 - 1868 pg/mL)
Expected Values (Reference Range Verification)	Percentage of samples falling within the predicate's reference range (12-85 pg/mL) should be high (e.g., ≥95%).	Plasma (Lot 1 & 2): 100.0% within range Serum (Lot 1): 97.5% within range Serum (Lot 2): 95.0% within range
Stability	Reagent stability confirmed for claimed periods.	On-board stability: 28 days (with 14-day calibration interval). Reagent stable until printed date at 2-8°C.

2. Sample Size Used for the Test Set and the Data Provenance

Precision: 7 samples (4 EDTA plasma pools, 3 commercial control materials). No specific provenance (country of origin) mentioned, but likely clinical samples and commercial controls from within Siemens' testing facilities or sourced according to industry standards.
Detection Limits (LoB, LoD, LoQ): A single blank (Multi-Diluent 11) and 5 test samples (spiked/diluted plasma samples). Each sample tested n=6 x 2 instruments x 5 days (total n=60 per reagent lot for 2 reagent lots). Provenance not specified.
Linearity / Assay Range: 12 test concentrations (pools). Provenance not specified.
High Dose Hook Effect: One hook sample. Provenance not specified.
Interfering Substances: Two patient plasma pools. Provenance not specified.
Cross-reacting Substances: A plasma sample with endogenous iPTH and an assay-specific diluent. Provenance not specified.
Method Comparison: 106 unaltered native matched serum and plasma samples. No specific provenance (country of origin) or retrospective/prospective status explicitly stated. Clinical samples are typically retrospective or prospectively collected for validation studies.
Expected Values (Reference Range Verification): 40 plasma and 40 serum samples. Obtained from "apparently healthy individuals" (implying human clinical samples). Provenance not specified.

All studies appear to be retrospective in nature, as they involve testing existing samples or prepared samples under controlled conditions to evaluate device performance characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For this type of in vitro diagnostic device (immunoassay), ground truth is not typically established by human expert review in the same way it would be for imaging diagnostics.

Ground truth for quantitative assays like this one is generally established through:
- Reference Methods: Highly accurate and precise laboratory methods (e.g., mass spectrometry). While not explicitly stated for all measurements, this is the gold standard for establishing true analyte concentrations.
- Predicate Device: For method comparison, the predicate device's results serve as the comparison "truth" against which the modified device is evaluated.
- Defined Concentrations: For studies like linearity, precision, and detection limits, samples are often prepared with known, spiked, or characterized concentrations.

There is no mention of human "experts" establishing ground truth for individual test samples. The "experts" involved are implied to be the laboratory personnel, scientists, and statisticians who designed and conducted the studies, and who interpret the results against established statistical and clinical criteria (e.g., CLSI guidelines).

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where multiple human readers assess findings and resolve discrepancies. Here, the "truth" for evaluation is based on quantitative measurements.

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 a laboratory immunoassay, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is a standalone device. The performance characteristics (precision, linearity, detection limits, interference, cross-reactivity, method comparison) are all evaluations of the assay itself, demonstrating its analytical performance without any human intervention beyond standard laboratory procedures for running the test. It's a fully automated system for quantitative determination.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used in these studies is primarily based on:

Reference standards/known concentrations: For linearity, precision, and detection limit studies, samples are often prepared with known concentrations or characterized against highly accurate reference methods.
Values from the predicate device: For method comparison, the results obtained from the predicate device serve as the comparative "ground truth."
Clinical status for reference ranges: Normal healthy individuals are used to verify the expected reference range.

8. The Sample Size for the Training Set

Not applicable in the traditional sense of machine learning. This device is an immunoassay, not a machine learning algorithm that requires a "training set" to learn a model. Its performance is based on the chemical and immunological reactions of the assay components.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated above (not an ML-based device requiring a training set). The assay's performance is driven by its reagent formulation and instrument design, which are developed and validated through iterative testing and process control during manufacturing.

Summary

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510(k) Summary of Safety and Effectiveness for the

FEB - ち 2014

ADVIA® Centaur Intact Parathyroid (iPTH) Assay

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. 510(k) Number: K133601

B. Date of Preparation: February 4, 2014

C. Proprietary and Established Names:

ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay

D. Applicant:

Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Philip Liu, Ph.D. Senior Manager, Regulatory Affairs and Compliance Office: (914) 524-2443 Fax: (914) 524-3579

E. Regulatory Information:

1. Regulation section: 21 CFR § 862.1545
1. Classification: Class II
1. Product Code: CEW, Parathvroid Hormone Test System
1. Panel: Clinical Chemistry

F. Predicate Device:

The ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay using the ADVIA Centaur XP was cleared under 510(k) K121981. The assay is also being marketed on the instrument family member, ADVIA Centaur, following FDA's Replacement Reagent and Instrument Family Policy (December 11, 2003).

G. Intended Use / Indications for Use:

The ADVIA Centaur iPTH assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

H. Device Description:

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goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.

The ADVIA Centaur iPTH reagent kit contains the following:

ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid . Phase Reagent)
ADVIA Centaur iPTH Master Curve card .

Materials Required but Not Provided

iPTH Calibrator .
Optional Reagents
ADVIA Centaur Multi-Diluent 11 .
iPTH 1, 2, 3 quality control material .
. iPTH Master Curve Material

I. Description of Device Modification

The modification to the ADVIA Centaur iPTH assay is due to the qualification of new . polyclonal goat anti-human PTH antibody pools:

Newly qualified pool for polyclonal goat anti-human PTH N- terminal antibody . (Lite Reagent) produced by Siemens (Elkhart).
Newly qualified pool for polyclonal goat anti-human PTH C- terminal antibody . (Solid Phase Reagent) produced by Siemens (Elkhart).

J. Comparison of Predicate Device and Modified Device:

The following table provides a comparison between the Predicate ADVIA Centaur iPTH assay (with the current polyclonal antibody pools) and the modified ADVIA Centaur iPTH assay with the newly-qualified polyclonal antibody pools.

	Modified Device:ADVIA Centaur Intact PTH Assay	Predicate Device:ADVIA Centaur Intact PTH Assay
Intended Use	For in vitro diagnostic use in thequantitative determination of intactparathyroid hormone (iPTH) in EDTAplasma or serum using the ADVIACentaur* and ADVIA Centaur XPsystems	Same* ADVIA Centaur was added afterclearance following the guidelines of theFDA's Replacement Reagent andInstrument Family Policy
Indications forUse	This assay is intended to be used toaid in the differential diagnosis ofhyperparathyroidism andhypoparathyroidism.	Same
Sample type	EDTA Plasma, Serum	Same
Measurement	Quantitative	Same
OperatingPrinciple	Sandwich immunoassay	Same
Technology	Chemiluminescence	Same
DetectionAntibody	Goat polyclonal antibody conjugatedto Acridium Ester	Same

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Item	Modified Device:ADVIA Centaur Intact PTH Assay	Predicate Device:ADVIA Centaur Intact PTH Assay
CaptureAntibody	Goat polyclonal antibody conjugatedto biotin directly coupled tostreptavidin magnetic particles	Same
Assay Range	6.3 - 1900 pg/mL	5.5 - 1900 pg/mL
Sample Volume	200 it is not possible to generate a valid JSON from the image. The image contains a table with text and numerical data, but it does not conform to the structure of a JSON object or array. JSON requires key-value pairs or a structured array of objects, which is not present in the image. Therefore, I cannot provide a valid JSON output based on the image. Instead, I will return

K. Standard/Guidance Document Referenced:

CLSI Guideline EP5-A2: Evaluation of Precision Performance of Qualitative . Measurement Methods
CLSI Guideline EP17-A2: Evaluation of Detection Capability for Clinical . Laboratory Measurement Procedures
. CLSI Guideline EP6-A: Evaluation of the Linearity of Qualitative Measurement Methods
CLSI Guideline C28-A3c: Defining, Establishing, and Verifying Reference . Intervals in the Clinical Laboratory: Approved Guideline
CLSI Guideline EP7-A2: Interference Testing in Clinical Chemistry; Approved . Guideline
. Medical devices - Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R) 2010)

L. Performance Characteristics

Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, interfering and cross-reacting substances, and method comparison.

a. Precision

Precision was evaluated following CLSI guideline EP5-A2. Two replicates of each of 7 samples including 4 EDTA plasma pools and 3 levels of commercial control materials were assayed in duplicate over the course of 20 days, on 2 instruments using 2 lots of reagent, two runs per day, for a total of 40 runs and 80 replicates. A representative lot is summarized below:

Sample	MEAN (pg/mL)	Within Run %CV	Total %CV
Pool 1	16.1	7.1	7.7
Control 1	38.7	3.6	4.7
Pool 2	62.8	2.7	3.7
Control 2	185	2.4	3.2
Control 3	663	2.2	2.8

Siemens Healthcare Diagnostics ADVIA Centaur iPTH Traditional 510(k) K133601

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Sample	MEAN (pg/mL)	Within Run %CV	Total %CV
Pool 3	839	3.0	3.9
Pool 4	1698	2.3	3.2

b. Detection Limits

The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were estimated per CLSI EP17-A2. The LoB was calculated non-parametrically. The LoQ was estimated as the dose corresponding to 20% Total CV using the precision profile method.

A single experimental design was used to generate the data for LoB, LoD and LoQ. Multi-Diluent 11 (assay specific diluent) was used as the blank. Five test samples were prepared by spiking analyte into diluent and/or diluting plasma samples to obtain the following approximate concentrations: 1, 2, 5, 10, and 15 pg/mL. These samples were tested at n=6 x 2 instruments x 5 days for a total of n=60 per reagent lot (2 reagents lots were used).

The results are as follows:

LoB	LoD	LoQ
0.1 pg/mL	2.7 pg/mL	6.3 pg/mL

c. Linearity / Assay Range

Linearity across the assay range was evaluated following the guidelines of CLSI EP6-A. Twelve test concentrations (pools) ranging from 4.4 to 2021 pg/mL were prepared by dilution of high and low concentration pools. Testing of the pools across the assay range was done with one reagent lot.

The regression statistics (Observed vs. Expected Values with weighed linear fit) for the linearity study were as follows:

v= 0.98x - 4.98, R = 1.00

d. High Dose Hook Effect

High dose hook effect was tested. A hook sample was prepared by spiking iPTH stock into diluent to achieve a concentration of approximately 144,000 pg/mL. The hook sample was tested in triplicate with 2 reagent lots. No high dose hook was observed for either reagent lot.

e. Interfering Substances

Interference by hemoglobin, triglycerides, bilirubin, and biotin was evaluated using two patient plasma pools with endogenous iPTH concentrations of ~20 pg/mL and ~200 pg/mL. There was no indication of interference (≤ 10% effect) up to the interferent levels claimed.

Siemens Healthcare Diagnostics ADVIA Centaur iPTH Traditional 510(k) K133601

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InterferingSubstance	Conc.	TestSample(pg/mL)	ControlSample(pg/mL)	% Bias
Hemoglobin	500 mg/dL	30.9	29.6	4%
		203	204	-1%
Triglycerides	3000 mg/dL	27.4	25.7	7%
		153	148	-4%
ConjugatedBilirubin	40 mg/dL	31.8	29.8	7%
		212	211	0%
UnconjugatedBilirubin	40 mg/dL	24.1	22.5	7%
		197	183	8%
Biotin	1000 ng/mL	32.6	30.0	8%
		222	236	6%

f. Cross reacting Substances

Cross reactivity was evaluated using a plasma sample with endogenous iPTH and an assay specific Multi-diluent 11 (buffered goat serum with no analyte). No cross reactivity was observed at the highest levels tested with the exception of the PTH 7 -84 fragment (~ 51%).

Cross reactant	Conc.(pg/mL)	Multi-Dil 11IPTH Dose(pg/mL)	%CrossReactivity	IPTH Dose(pg/mL)	%CrossReactivity
PTH 1-34	300	0.0	-0.2	33.9	0.1
PTH 39-68	100,000	0.1	0.0	22.2	0.0
PTH 39-84	100,000	2.7	0.0	17.5	0.0
PTH 44-68	100.000	0.0	0.0	23.4	0.0
PTH 53-84	100,000	2.0	0.0	27.1	0.0
Calcitonin	100,000	0.0	0.0	33.1	0.0
PTH 7-84	300	130	33	192	51
Beta-Cross Laps	1000	0.5	0.0	35.8	0.2
Osteocalcin	50,000	0.2	0.0	34.7	0.0

g. Method Comparison

Method Comparison studies were done with 106 unaltered native matched serum and plasma samples to demonstrate equivalence to the Predicate (ADVIA Centaur iPTH assay). The ADVIA Centaur iPTH assay shows good correlation in sample results compared to the Predicate.

System (y)	N	RegressionEquation*	R**	Sample Range(pg/mL)
ADVIA Centaur iPTH(EDTA Plasma)	106	$y = 0.98x + 10.6$	1.00	11.8 - 1862
ADVIA Centaur iPTH(Serum)	105 ***	$y =1.00x + 5.0$	1.00	9.8 - 1868

x =Predicate (ADVIA Centaur iPTH Assay)

Passing & Bablok

** Least Squares Linear regression

*** Sample outside of assay range was excluded

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h. Expected Values

The reference range of the Predicate was verified following the guidelines of CLSI C28-A3c. Forty (40) plasma and 40 serum samples obtained from apparently healthy individuals (calcium and inorganic phosphorus results within their respective reference ranges) were tested using 2 reagent lots across 4 instruments. The results are as follows:

	% Within Range
	Plasma	Serum
Range	Lot 1	Lot 2	Lot 1	Lot 2
12 85pg/mL	100.0%	100.0%	97.5%	95.0%

i. Stabilitv

The on board stability of the reagent is 28 days with a calibration interval of 14 days. The ADVIA Centaur Intact PTH assay reagent is stable until the date printed on the label when stored at 2-8°C.

M. Conclusions

Comparative testing of the modified ADVIA Centaur iPTH assay is substantially equivalent in principle and performance to the Predicate Device, ADVIA Centaur Intact PTH assay, cleared under 510(k) K121981.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2014

SIEMENS HEALTHCARE DIAGNOSTICS INC. DR. PHILIP LIU SENIOR MANAGER, REGULATORY AFFAIRS 511 BENEDICT AVE. TARRYTOWN NY 10591

Re: K133601

Trade/Device Name: ADVIA Centaur Intact Parathyroid Hormone (iPTH) Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: December 30, 2013 Received: December 31, 2013

Dear Dr. Liu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Dr. Liu

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133601

Device Name

ADVIA Centaur® Intact Parathyroid Hormone (iPTH) assay

Indications for Use (Describe)

The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE SECT THE CONFORT FOR FOR FOR FOR MANAGE ONLY FOR CONSTITUTION OF CONSULTION OF CONSULTION OF Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.