Access Intact PTH
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 |
Indications for 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)
Related Devices
- K061190 — ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 · Beckman Coulter, Inc. · Sep 15, 2006
- K070709 — ROCHE ELECSYS PTH TEST SYSTEM · Roche Diagnostics Corp. · Jul 13, 2007
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K232791
B Applicant
Beckman Coulter, Inc.
C Proprietary and Established Names
Access Intact PTH
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CEW | Class II | 21 CFR 862.1545 - Parathyroid Hormone Test System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modified device
B Measurand:
Parathyroid Hormone
C Type of Test:
Quantitative, Immunoenzymatic assay
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for 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.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
DxI 9000 Access Immunoassay Analyzer
IV Device/System Characteristics:
A Device Description:
The device consists of the components described below.
Access Intact PTH (iPTH) Reagent Pack:
- R1a: 3.25 mL, Paramagnetic particles coated with goat anti-PTH antibody suspended in TRIS buffered saline with bovine serum albumin (BSA), surfactant, < 0.1% sodium azide, 0.1% ProClin 300.
- R1b: 3.1 mL, TRIS buffered saline with block ACE, protein (mouse, goat), surfactant, < 0.1% sodium azide, 0.1% ProClin 300.
- R1c: 3.1 mL, Mouse monoclonal anti-PTH alkaline phosphatase conjugate in ACES buffered saline with BSA, surfactant, < 0.1% sodium azide, 0.1% ProClin 300.
Materials Required but Not Provided
The Beckman Coulter Access Intact PTH (iPTH) Assay is designed for use in conjunction with the following products:
- Access Intact PTH Calibrators
- Lumi-Phos PRO Substrate
- Unicell Dxl Wash Buffer II
- Access Sample Diluent A
B Principle of Operation:
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. The assay principle uses a two-site immunoenzymatic (“sandwich”) assay, where a sample (55 μL) is added to a reaction vessel, along with a monoclonal anti-PTH antibody conjugated to alkaline phosphatase, TRIS buffered saline with proteins and paramagnetic particles coated with a goat polyclonal anti-PTH antibody. Samples may be run in one of two modes: routine mode (≤ 30 minutes from start of sample pipetting to test result) and intraoperative mode (≤ 15 minutes from start of sample pipetting to test result). After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Access Intact PTH
B Predicate 510(k) Number(s):
K061190
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232791 | K061190 |
| --- | --- | --- |
| Device Trade Name | Access Intact PTH assay | Access Intact PTH assay |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. | Same |
| Sample type | Serum or Plasma (Heparin and EDTA) | Same |
| General Device Characteristic Differences | | |
| Measuring range | 1.7 – 3,500 pg/mL | 1 – 3,500 pg/mL |
| Substrate | Lumi-Phos PRO Substrate | Access Substrate |
| Analyzer platform | DxI 9000 Access Immunoassay Analyzer | Access 2 Immunoassay system |
VI Standards/Guidance Documents Referenced:
- Clinical & Laboratory Standards Institute (CLSI) EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
- CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
- CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
- CLSI EP06-2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
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VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Routine Mode:
A precision study was performed in accordance with CLSI EP05-A3. Five serum samples with PTH concentrations spanning the analytical range were tested using three reagent lots on three DxI 9000 Access Immunoassay Analyzers. Samples were assayed in duplicate using 2 runs per day over 20 days for a total of 80 replicates per sample per lot. Results from multiple lots were similar. Within-run (repeatability), within-lab (total), between-run, and between-day precision results for a representative reagent lot on a single instrument are summarized below:
| Concentration (pg/mL) | | | Repeatability (Within-run) | | Between-run | | Between-day | | Within- Laboratory (Total) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean pg/mL | SD pg/mL | %CV | SD pg/mL | %CV | SD pg/mL | %CV | SD pg/mL | %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 |
Intraoperative Mode:
A precision study was performed in accordance with CLSI EP05-A3. Seven serum samples were tested using three reagent lots on three DxI 9000 Access Immunoassay Analyzers. Seven serum samples with PTH concentrations spanning the analytical range were assayed in duplicate using 2 runs per day over 20 days for a total of 80 replicates per sample per lot. Results from multiple lots were similar. Within-run (repeatability), within-lab (total), between-run, and between-day precision results for a representative reagent lot on a single instrument are summarized below:
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| Concentration (pg/mL) | | | Repeatability (Within-run) | | Between-run | | Between-day | | Within- Laboratory (Total) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean pg/mL | SD pg/mL | %CV | SD pg/mL | %CV | SD pg/mL | %CV | SD pg/mL | %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 |
2. Linearity:
Linearity studies were performed using serum samples across the assay measuring range to evaluate the linearity of the Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer in accordance with the CLSI Guideline EP06-Ed2. The data was analyzed using a weighted linear regression model. The deviation from linearity for the routine mode did not exceed 5% and for the intraoperative mode, did not exceed 8%.
The results of these linearity studies support that the Access Intact PTH assay is linear on the DxI 9000 Access Immunoassay Analyzer throughout the proposed analytical measuring interval of 1.7 – 3,500 pg/mL.
3. Analytical Specificity/Interference:
Interference was previously established in K061190. The sponsor provided information to support that biotin up to 3500 ng/mL does not interfere with the test.
4. Assay Reportable Range:
See Linearity section above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Access Intact PTH assay is traceable to international WHO standard 79/500.
6. Detection Limit:
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) were evaluated based on the CLSI guideline EP17-A2. The LoQ was defined as the lowest concentration of analyte which has imprecision less than or equal to 20% CV.
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The LoB, LoD, and LoQ results are summarized below:
| Mode | LoB | LoD | LoQ |
| --- | --- | --- | --- |
| Routine | 0.5 pg/mL | 0.7 pg/mL | 0.7 pg/mL |
| Intraoperative | 0.5 pg/mL | 0.8 pg/mL | 0.8 pg/mL |
7. Assay Cut-Off: Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device: Routine Mode: A method comparison study was completed to compare the candidate device to the predicate device in routine mode in accordance with CLSI EP09c 3rd Edition. Weighted Deming analysis was performed, and the results are summarized below.
| N | Sample range tested (pg/ml) | Slope | Intercept (pg/mL) | Correlation Coefficient (r) |
| --- | --- | --- | --- | --- |
| 144 | 1.9 - 3233 | 0.97 | -0.23 | 1.00 |
Intraoperative Mode: A method comparison study was completed to compare the Access PTH Intraoperative mode (PTH-IO) assay on DxI 9000 Access Immunoassay Analyzer to the predicate device, the Access PTH assay (Routine mode) on the Access 2 Immunoassay System in accordance with CLSI EP09c 3rd Edition. Weighted Deming analysis was performed, and the results are summarized below.
| N | Sample range tested (pg/ml) | Slope | Intercept (pg/mL) | Correlation Coefficient (r) |
| --- | --- | --- | --- | --- |
| 116 | 2.1-3275 | 1.02 | -0.081 | 0.99 |
A supplemental study was performed comparing the performance of the Access PTH assay in the Intraoperative mode on the DxI 9000 Access Immunoassay Analyzer to the Access 2 Immunoassay system. The results demonstrated that the performance of the device was not impacted by modifications to the device.
2. Matrix Comparison: Previously established in K061190.
## C Clinical Studies:
1. Clinical Sensitivity: Not applicable.
2. Clinical Specificity: Not applicable.
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3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D. Clinical Cut-Off:
Not applicable.
E. Expected Values/Reference Range:
Data establishing the reference range for the Access Intact PTH assay was previously reviewed in K061190.
VIII. Proposed Labeling:
The labeling does support the finding of substantial equivalence for this device.
IX. Conclusion:
The submitted information in this premarket notification is complete and does support a substantial equivalence decision.
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