Access Intact PTH

K232791 · Beckman Coulter, Inc. · CEW · Mar 1, 2024 · Clinical Chemistry

Device Facts

• Record ID: K232791
• Device Name: Access Intact PTH
• Applicant: Beckman Coulter, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Mar 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

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 Story

Access Intact PTH is a sandwich immunoenzymatic assay for quantitative PTH measurement. Input: human serum or plasma samples. Process: sample reacts with monoclonal anti-PTH antibody conjugated to alkaline phosphatase and paramagnetic particles coated with goat polyclonal anti-PTH antibody; chemiluminescent signal generated via substrate. Output: quantitative PTH concentration (pg/mL or pmol/L). Used in clinical laboratory settings on Dxl 9000 Access Immunoassay Analyzers; operated by laboratory technicians. Results assist clinicians in diagnosing parathyroid disorders and managing patients, including intraoperative monitoring. Benefits: provides rapid, accurate hormone quantification to guide surgical or medical intervention.

Clinical Evidence

No clinical studies performed. Analytical performance established via bench testing: precision (CLSI EP05-A3), linearity (CLSI EP06-Ed2), and method comparison (CLSI EP09c) against predicate. Precision studies (N=80-88 replicates) showed within-lab CVs ranging from 2.7% to 13.2%. Linearity confirmed across 1.7–3,500 pg/mL range. Method comparison (N=144 routine; N=116 intraoperative) demonstrated slopes of 0.97 and 1.02 respectively, with correlation coefficients ≥0.99.

Technological Characteristics

Sandwich immunoenzymatic assay; paramagnetic particle solid support; chemiluminescent detection. Reagents: monoclonal anti-PTH antibody-alkaline phosphatase conjugate, goat polyclonal anti-PTH antibody-coated particles. Measuring range: 1.7–3,500 pg/mL. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos PRO. Calibration: 6-level synthetic PTH antigen. Stability: 28 days at 2–10°C.

Indications for Use

Indicated for quantitative determination of intact parathyroid hormone in human serum and plasma to aid in differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy; can be used intraoperatively. For prescription use only.

Regulatory Classification

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

• Access Intact PTH (K061190)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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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2

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 ([e-mail]) or phone [phone] 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)

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.

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: [e-mail] Phone: [phone]

#### Alternate Contact:

Kuljeet Kaur, Regulatory Affairs Manager Email: [e-mail] Office Phone: [phone]

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

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.

#### Intended Use

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.

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| | Comparison of Technological Characteristics to the Predicate (Assay) | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | | |
| System<br>Attribute/Characteristic | Predicate Access Intact PTH<br>on Access 2 Immunoassay<br>System | Access Intact PTH on Dxl<br>9000 Access Immunoassay<br>Analyzer |
| Intended Use/<br>Indications for Use | The Access Intact PTH assay<br>is a paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>intact parathyroid hormone<br>(parathyrin, PTH) levels in<br>human serum and plasma<br>using the Access<br>Immunoassay Systems. It is<br>indicated to aid in the<br>differential diagnosis of<br>hyperparathyroidism,<br>hypoparathyroidism, or<br>hypercalcemia of malignancy<br>and can be used<br>intraoperatively. Assay results<br>should be used in conjunction<br>with other clinical data to<br>assist the clinician in making<br>individual patient management decisions. | Same |
| Assay Principle | The Access Intact PTH assay<br>is a two-site immunoenzymatic<br>( "sandwich" ) assay. A<br>sample is added to a reaction<br>vessel, along with a<br>monoclonal anti-PTH antibody<br>conjugated to alkaline<br>phosphatase, TRIS buffered<br>saline with proteins and<br>paramagnetic particles coated<br>with a goat polyclonal anti-<br>PTH antibody. | Same |
| Solid Support | Paramagnetic Particles | Same |
| Calibration | Six levels (10, 60, 300, 1,500<br>and 3,500 pg/mL) of synthetic<br>PTH antigen in a buffered<br>protein solution with<br>preservatives | Same |
| Sample Type | Serum or Plasma (Heparin<br>and 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 |
| System<br>Attribute/Characteristic | Predicate Access Intact PTH<br>on Access 2 Immunoassay<br>System | Access Intact PTH on Dxl<br>9000 Access Immunoassay<br>Analyzer |
| Instrument | Access 2 Immunoassay<br>system | Dxl 9000 Access<br>Immunoassay 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<br>(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<br>(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<br>(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<br>(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 | 0.00<br>3 | 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<br>(LoB) | 0.5 | 0.05 | ≤ 1.0 | ≤ 0.11 |
| Limit of Detection<br>(LoD) | 0.7 | 0.08 | ≤ 1.0 | ≤ 0.11 |
| Limit of<br>Quantitation (LoQ)<br>≤ 20% within-lab<br>CV | 0.7 | 0.08 | ≤ 1.7 | ≤ 0.18 |

| | | Maximum Observed Result | | Design Criteria | |
|-----------------------------|-------|-------------------------|-------|-----------------|--|
| INTRAOPERATIVE<br>MODE | pg/mL | pmol/L | pg/mL | pmol/L | |
| Limit of Blank (LoB) | 0.5 | 0.05 | ≤ 1.0 | ≤ 0.11 | |
| Limit of Detection<br>(LoD) | 0.8 | 0.08 | ≤ 1.0 | ≤ 0.11 | |

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| | Maximum Observed Result | | Design Criteria | |
|-------------------------------------------------------|-------------------------|--------|-----------------|--------|
| INTRAOPERATIVE<br>MODE | pg/mL | pmol/L | pg/mL | pmol/L |
| Limit of Quantitation<br>(LoQ)<br>≤ 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 | Concentration<br>Range*<br>(pg/mL) | Slope | Slope<br>95% CI | Intercept | Intercept<br>95% CI | Correlation<br>Coefficient<br>R |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 144 | 2.2 - 3278 | 0.97 | 0.96 - 0.98 | -0.23 | -0.33 - (-0.12) | 1.00 |

| N | Concentration<br>Range*<br>(pmol/L) | Slope | Slope<br>95% CI | Intercept | Intercept<br>95% CI | Correlation<br>Coefficient<br>R |
|-----|-------------------------------------|-------|-----------------|-----------|-----------------------|---------------------------------|
| 144 | 0.23 - 347 | 0.97 | 0.96 - 0.98 | -0.024 | -0.035 - (-<br>0.013) | 1.00 |

### INTRAOPERATIVE MODE:

| N | Concentrati<br>on Range*<br>(pg/mL) | Slope | Slope<br>95% CI | Intercept | Intercept<br>95% CI | Correlation<br>Coefficient<br>R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 116 | 2.3 - 3677 | 1.02 | 1.00 - 1.04 | -0.081 | -0.36 - 0.20 | 0.99 |

| N | Concentrati<br>on Range*<br>(pmol/L) | Slope | Slope<br>95% Cl | Intercept | Intercept<br>95% Cl | Correlation<br>Coefficient<br>R |
|-----|--------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 116 | 0.24 - 390 | 1.02 | 1.00 - 1.04 | -0.0086 | -0.038 -<br>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.