The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Device Description

The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.

AI/ML Overview

The provided text describes the performance validation of the Beckman Coulter Access Intact PTH assay on the Dxl 9000 Access Immunoassay Analyzer. This is a biomedical measurement device, specifically an in vitro diagnostic (IVD) rather than an AI-powered system as might be initially implied by the format of the request. Therefore, some of the requested information regarding AI-specific criteria (like number of experts for ground truth, adjudication methods, MRMC studies, training set details) is not applicable to this type of device.

Here's an analysis of the acceptance criteria and study results, focusing on the relevant aspects for an IVD device:

Acceptance Criteria and Reported Device Performance

The study primarily focuses on demonstrating the performance characteristics of the Access Intact PTH assay run on the Dxl 9000 system, compared to its predicate device (Access Intact PTH on the Access 2 Immunoassay System). The "acceptance criteria" here are performance targets related to analytical precision, linearity, and detection/quantitation limits, based on standard laboratory guidelines (CLSI documents).

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Design Criteria)	Reported Device Performance (Routine Mode)	Reported Device Performance (Intraoperative Mode)
Imprecision (Within-Laboratory)	≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L) ≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L)	SD: Sample 1: 0.46 pg/mL (0.05 pmol/L) %CV: Sample 1: 5.9%, Sample 2: 6.5%, Sample 3: 4.3%, Sample 4: 3.7%, Sample 5: 2.7%	SD: Sample 1: 0.23 pg/mL (0.02 pmol/L) %CV: Sample 1: 13.2% (exceeds 8%), Sample 2: 5.0%, Sample 3: 4.8%, Sample 4: 4.2%, Sample 5: 4.0%, Sample 6: 4.3%, Sample 7: 3.3%
Linearity	(Implicitly: demonstrate linearity across measuring interval)	Demonstrated linearity across measuring interval (1.7 - 3500 pg/mL)	Demonstrated linearity across measuring interval (1.7 - 3500 pg/mL)
Limit of Blank (LoB)	≤ 1.0 pg/mL (≤ 0.11 pmol/L)	0.5 pg/mL (0.05 pmol/L)	0.5 pg/mL (0.05 pmol/L)
Limit of Detection (LoD)	≤ 1.0 pg/mL (≤ 0.11 pmol/L)	0.7 pg/mL (0.08 pmol/L)	0.8 pg/mL (0.08 pmol/L)
Limit of Quantitation (LoQ) (≤ 20% within-lab CV)	≤ 1.7 pg/mL (≤ 0.18 pmol/L)	0.7 pg/mL (0.08 pmol/L)	0.8 pg/mL (0.08 pmol/L)
Method Comparison (vs. Predicate)	(Implicitly: demonstrate substantial equivalence with predicate)Expected slopes near 1.0 and intercepts near 0,
high correlation (R near 1.0)	Slope: 0.97 (95% CI: 0.96-0.98) Intercept: -0.23 (95% CI: -0.33 to -0.12) Correlation (R): 1.00	Slope: 1.02 (95% CI: 1.00-1.04) Intercept: -0.081 (95% CI: -0.36 to 0.20) Correlation (R): 0.99

Notes on Performance:

For Imprecision, one sample in the "Intraoperative Mode" (Sample 1, 1.7 pg/mL) shows a %CV of 13.2%, which exceeds the general criteria of "≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L)" and also "≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L)". However, given the actual concentration and the stated SD for this sample (0.23 pg/mL), it might be acceptable for very low concentrations where relative variability can be higher, or it might fall into a specific acceptance sub-criterion not fully detailed here. The SD of 0.23 pg/mL is still well below the 0.96 pg/mL SD target for concentrations ≤ 12 pg/mL.
The correlation coefficients (R) of 1.00 and 0.99 for method comparison indicate excellent agreement with the predicate device. The slopes and intercepts also demonstrate good agreement, supporting the claim of substantial equivalence.

Study Details:

As this is a 510(k) submission for an in vitro diagnostic immunoassay system, the concept of AI-driven image analysis or clinical decision support is not applicable. Therefore, many of the questions related to AI-specific validation (e.g., number of experts, adjudication, MRMC studies, AI training sets) are not relevant to this document. The "ground truth" for an IVD refers to the true concentration of an analyte as measured by a reference method or established through rigorous characterization of control materials.

Sample sizes used for the test set and data provenance:
- Imprecision Study:
  - Routine Mode: 86 replicates for most samples (one sample with 84 replicates).
  - Intraoperative Mode: 88 replicates for all samples.
  - Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting (prospective data collection from prepared samples/controls). No country of origin for the data is specified, but given the manufacturer (Beckman Coulter, Inc., Chaska, MN, USA), it's highly likely to be US-based or from their global R&D facilities.
- Method Comparison Study:
  - Routine Mode: N=144 patient samples.
  - Intraoperative Mode: N=116 patient samples.
  - Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. These are typically patient plasma/serum samples collected prospectively for the study or from biobanks.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an immunoassay device for quantitative determination of a hormone. The "ground truth" for these tests is based on the chemical measurement itself, validated against reference materials or established methods, not subjective expert interpretation of images or clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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 an automated immunoassay system, not an AI-assisted diagnostic tool requiring human reader interpretation studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This entire validation represents the "standalone" performance of the analytical instrument and assay kit. The Dxl 9000 Access Immunoassay Analyzer functions largely as an automated "algorithm" in that it processes samples and produces quantitative results without direct human interpretive input during the measurement process. Human oversight and quality control are part of its real-world use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this immunoassay is likely established through:
  - Reference Materials/Calibrators: These are materials with precisely known concentrations of intact PTH, used to calibrate the instrument and verify accuracy.
  - Predicate Device Comparison: The "Method Comparison" study uses the results from the legally marketed predicate device (Access Intact PTH on the Access 2 Immunoassay System) as the comparative reference, implicitly relying on the established accuracy of that predicate.
  - Analytical Standards: Performance metrics (LoB, LoD, LoQ, linearity) are assessed against internationally recognized analytical standards, such as those from CLSI (Clinical and Laboratory Standards Institute), which define the statistical and experimental methods for confirming these basic analytical performance parameters.
The sample size for the training set:
- Not Applicable. This is an immunoassay device, not an AI/machine learning model that requires a "training set" in the conventional sense. The "training" of the device involves calibration using specified calibrator materials and internal quality control procedures.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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March 1, 2024

Beckman Coulter, Inc. Neha Desai Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: K232791

Trade/Device Name: Access Intact PTH Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: January 22, 2024 Received: January 22, 2024

Dear Neha Desai:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director

Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K232791 Device Name

Access Intact PTH

Indications for Use (Describe)

lt is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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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.

510(k) Number K232791

Submitter Name and Address:

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Primarv Contact:

Neha Desai, Staff Quality and Regulatory Affairs Email: nhdesai@beckman.com Phone: (612) 244-9788

Alternate Contact:

Kuljeet Kaur, Regulatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914

Trade Name: Access Intact PTH Common Name: Parathvroid Hormone Test Classification Requlation: 21 CFR 862.1545 Classification Product Code: CEW

Predicate Device:

Access Intact PTH 510(k) Number K061190

Device Description

Intended Use

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	Comparison of Technological Characteristics to the Predicate (Assay)

SystemAttribute/Characteristic	Predicate Access Intact PTHon Access 2 ImmunoassaySystem	Access Intact PTH on Dxl9000 Access ImmunoassayAnalyzer
Intended Use/Indications for Use	The Access Intact PTH assayis a paramagnetic particle,chemiluminescentimmunoassay for thequantitative determination ofintact parathyroid hormone(parathyrin, PTH) levels inhuman serum and plasmausing the AccessImmunoassay Systems. It isindicated to aid in thedifferential diagnosis ofhyperparathyroidism,hypoparathyroidism, orhypercalcemia of malignancyand can be usedintraoperatively. Assay resultsshould be used in conjunctionwith other clinical data toassist the clinician in makingindividual patient management decisions.	Same
Assay Principle	The Access Intact PTH assayis a two-site immunoenzymatic( "sandwich" ) assay. Asample is added to a reactionvessel, along with amonoclonal anti-PTH antibodyconjugated to alkalinephosphatase, TRIS bufferedsaline with proteins andparamagnetic particles coatedwith a goat polyclonal anti-PTH antibody.	Same
Solid Support	Paramagnetic Particles	Same
Calibration	Six levels (10, 60, 300, 1,500and 3,500 pg/mL) of syntheticPTH antigen in a bufferedprotein solution withpreservatives	Same
Sample Type	Serum or Plasma (Heparinand EDTA)	Same
Measuring Range	1 - 3,500 pg/mL	1.7 - 3,500 pg/mL
Stability	Stable at 2 to 10°C for 28 days	Same
SystemAttribute/Characteristic	Predicate Access Intact PTHon Access 2 ImmunoassaySystem	Access Intact PTH on Dxl9000 Access ImmunoassayAnalyzer
Instrument	Access 2 Immunoassaysystem	Dxl 9000 AccessImmunoassay Analyzer
Substrate	Access Substrate	Lumi-Phos PRO substrate

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Standard/Guidance Document Referenced (if applicable):

CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition

CLSI EP06-2nd Edition -: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline

CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition

CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples- Third Edition

Summary of Studies:

Imprecision:

The Routine Mode assay and Intraoperative Mode assay were designed to have withinlaboratory imprecision as listed below:

≤ 0.96 pg/mL (0.10 pmol/L) SD at concentrations ≤ 12 pg/mL (1.3 pmol/L) .
≤ 8.0% CV at concentrations > 12 pg/mL (1.3 pmol/L) ●

A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days.

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Routine Mode:

	Concentration (pg/mL)			Repeatability(Within-Run)		Between-Run		Between-Day		Within-Laboratory
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Sample 1	86	7.8	0.19	2.4	0.10	1.2	0.41	5.2	0.46	5.9
Sample 2	86	12	0.48	3.9	0.40	3.3	0.48	4.0	0.79	6.5
Sample 3	86	89	2.1	2.3	2.1	2.3	2.4	2.7	3.8	4.3
Sample 4	86	1369	44.2	3.2	15.4	1.1	18.3	1.3	50.3	3.7
Sample 5	84	2449	48.9	2.0	14.2	0.6	40.8	1.7	65.2	2.7

	Concentration (pmol/L)		Repeatability(Within-Run)		Between-Run		Between-Day		Within-Laboratory
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Sample 1	86	0.83	0.02	2.4	0.01	1.2	0.04	5.2	0.05	5.9
Sample 2	86	1.3	0.05	3.9	0.04	3.3	0.05	4.0	0.08	6.5
Sample 3	86	9.4	0.22	2.3	0.22	2.3	0.25	2.7	0.40	4.3
Sample 4	86	145	4.7	3.2	1.6	1.1	1.9	1.3	5.3	3.7
Sample 5	84	260	5.2	2.0	1.5	0.6	4.3	1.7	6.9	2.7

IntraOperative Mode:

IntraOperative Mode:
	Concentration (pg/mL)		Repeatability(Within-Run)		Between-Run		Between-Day		Within-Laboratory
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Sample 1	88	1.7	0.15	8.6	0.13	7.3	0.12	6.9	0.23	13.2
Sample 2	88	6.6	0.27	4.1	0.03	0.4	0.19	2.9	0.33	5.0
Sample 3	88	14	0.6	4.0	0.0	0.0	0.4	2.7	0.7	4.8
Sample 4	88	34	1.3	4.0	0.0	0.0	0.5	1.4	1.4	4.2
Sample 5	88	169	5.5	3.3	3.1	1.8	2.4	1.4	6.8	4.0
Sample 6	88	1014	41.7	4.1	0.0	0.0	13.1	1.3	43.8	4.3
Sample 7	88	2542	72.3	2.8	41.7	1.6	0.0	0.0	83.5	3.3

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Concentration (pmol/L)		Repeatability(Within-Run)		Between-Run		Between-Day		Within-Laboratory
Sample	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Sample 1	88	0.18	0.02	8.6	0.01	7.3	0.01	6.9	0.02	13.2
Sample 2	88	0.70	0.03	4.1	0.003	0.4	0.02	2.9	0.03	5.0
Sample 3	88	1.5	0.06	4.0	0.0	0.0	0.04	2.7	0.07	4.8
Sample 4	88	3.6	0.14	4.0	0.0	0.0	0.05	1.4	0.15	4.2
Sample 5	88	18	0.6	3.3	0.3	1.8	0.3	1.4	0.7	4.0
Sample 6	88	107	4.4	4.1	0.0	0.0	1.4	1.3	4.6	4.3
Sample 7	88	269	7.7	2.8	4.4	1.6	0.0	0.0	8.9	3.3

Linearity:

A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ):

Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2. The LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.

		Maximum Observed Result	Design Criteria
ROUTINE MODE	pg/mL	pmol/L	pg/mL	pmol/L
Limit of Blank(LoB)	0.5	0.05	≤ 1.0	≤ 0.11
Limit of Detection(LoD)	0.7	0.08	≤ 1.0	≤ 0.11
Limit ofQuantitation (LoQ)≤ 20% within-labCV	0.7	0.08	≤ 1.7	≤ 0.18

		Maximum Observed Result		Design Criteria
INTRAOPERATIVEMODE	pg/mL	pmol/L	pg/mL	pmol/L
Limit of Blank (LoB)	0.5	0.05	≤ 1.0	≤ 0.11
Limit of Detection(LoD)	0.8	0.08	≤ 1.0	≤ 0.11

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	Maximum Observed Result		Design Criteria
INTRAOPERATIVEMODE	pg/mL	pmol/L	pg/mL	pmol/L
Limit of Quantitation(LoQ)≤ 20% within-lab CV	0.8	0.08	≤ 1.7	≤ 0.18

Method Comparison:

A study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.

ROUTINE MODE:

N	ConcentrationRange*(pg/mL)	Slope	Slope95% CI	Intercept	Intercept95% CI	CorrelationCoefficientR
144	2.2 - 3278	0.97	0.96 - 0.98	-0.23	-0.33 - (-0.12)	1.00

N	ConcentrationRange*(pmol/L)	Slope	Slope95% CI	Intercept	Intercept95% CI	CorrelationCoefficientR
144	0.23 - 347	0.97	0.96 - 0.98	-0.024	-0.035 - (-0.013)	1.00

INTRAOPERATIVE MODE:

N	Concentration Range*(pg/mL)	Slope	Slope95% CI	Intercept	Intercept95% CI	CorrelationCoefficientR
116	2.3 - 3677	1.02	1.00 - 1.04	-0.081	-0.36 - 0.20	0.99

N	Concentration Range*(pmol/L)	Slope	Slope95% Cl	Intercept	Intercept95% Cl	CorrelationCoefficientR
116	0.24 - 390	1.02	1.00 - 1.04	-0.0086	-0.038 -0.021	0.99

*Range is Access 2 values

Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Intact PTH assay on the Dxl 9000 Access Immunoassay Analyzer (K232791) is substantially equivalent to Intact PTH assay on the Access Immunoassay System (K061190) as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.

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.