Access Ostase
Device Facts
| Record ID | K232904 |
|---|---|
| Device Name | Access Ostase |
| Applicant | Beckman Coulter |
| Product Code | CIN · Clinical Chemistry |
| Decision Date | Apr 15, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
Indications for Use
The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Device Story
Access Ostase is a one-step sandwich immunoenzymatic assay used in clinical laboratories to measure bone alkaline phosphatase (BAP) in human serum or plasma. The device utilizes paramagnetic particles and chemiluminescent detection on the Dxl 9000 Access Immunoassay Analyzer. The assay transforms patient sample inputs into quantitative BAP concentration outputs. Healthcare providers use these results as an indicator of osteoblastic activity to assist in managing postmenopausal osteoporosis and Paget's disease. The system requires specific reagents, calibrators, quality controls, and the Lumi-Phos Pro substrate to function. The output is provided as a numerical value (µg/L) which informs clinical decision-making regarding bone health management.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP05-A3 (N=80 per sample, total CV 4.1-4.7%). Linearity confirmed per CLSI EP06-2nd Edition (0.3-120 μg/L). Detection limits (LoB 0.003, LoD 0.007, LoQ 0.3 μg/L) established per CLSI EP17-A2. Method comparison (N=163) against predicate showed high correlation (R=1.00) with Passing-Bablok slope of 0.95.
Technological Characteristics
One-step sandwich immunoenzymatic assay; paramagnetic particle, chemiluminescent detection. Analyte: Bone alkaline phosphatase (BAP). Measuring range: 0.3–120 µg/L. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos Pro. Standards referenced: CLSI EP05-A3 (precision), CLSI EP06-2nd Ed (linearity), CLSI EP17-A2 (detection capability), CLSI EP09c (method comparison).
Indications for Use
Indicated for the quantitative measurement of bone alkaline phosphatase (BAP) in human serum and plasma to aid in the management of postmenopausal osteoporosis and Paget's disease.
Regulatory Classification
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Predicate Devices
- Access Ostase Assay (K994278)
Related Devices
- K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY · Beckman Coulter, Inc. · Mar 28, 2000
- K200475 — IDS-iSYS Ostase BAP · Immunodiagnostic Systems , Ltd. · Sep 30, 2020
- K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY · Hybritech, Inc. · Sep 11, 1997
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
K232904
B Applicant
Beckman Coulter
C Proprietary and Established Names
Access Ostase
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CIN | Class II | 21 CFR 862.1050 - Alkaline Phosphatase Or Isoenzymes Test System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modified device
B Measurand:
Bone alkaline phosphatase
C Type of Test:
Quantitative immunoassay
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K232904 - Page 2 of 6
# B Indication(s) for Use:
The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
# C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro diagnostic use
# D Special Instrument Requirements:
DxI 9000 Access Immunoassay Analyzer
# IV Device/System Characteristics:
# A Device Description:
The chemiluminescent substrate was modified on the Access Ostase assay from the Access Substrate to the Lumi-Phos PRO substrate.
The Access Ostase reagent pack consists of two specific reagents, R1a, and R1b. A summary description of the reagents is provided below:
| Well | Contents | Ingredients |
| --- | --- | --- |
| R1a: | 3.25 mL | Paramagnetic particles coated with goat anti-mouse polyclonal antibody suspended in TRIS-buffered saline, with surfactant, bovine serum albumin (BSA), protein (goat), < 0.1% sodium azide, and 0.1% ProClin 300. |
| R1b: | 1.2 mL | Anti-BAP mouse monoclonal antibody diluted in TRIS-buffered saline, with surfactant, BSA, < 0.1% sodium azide, and 0.1% ProClin 300. |
Materials needed but not supplied with the reagent kit include the Access Ostase assay Calibrators, Quality Control (QC) materials, Lumi-Phos PRO, UniCel DxI Wash Buffer II, and Sample Diluent.
# B Principle of Operation:
The Access Ostase assay is a one-step sandwich immunoenzymatic assay. A mouse monoclonal antibody specific to BAP is added to a reaction vessel with paramagnetic particles coated with goat anti-mouse polyclonal antibody. 30 μL of calibrators, controls, or samples containing BAP are added to the coated particles, and bind to the anti-BAP monoclonal antibody.
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
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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 Ostase Assay
B Predicate 510(k) Number(s):
K994278
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232904 | K994278 |
| --- | --- | --- |
| Device Trade Name | Access Ostase | Access Ostase |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The device is intended for the quantitative measurement of bone alkaline phosphatase (BAP) as an aid in the management of postmenopausal osteoporosis and Paget's disease. | Same |
| Analyte Measured | Bone alkaline phosphatase (BAP) | Same |
| Technology | One-step immunoenzymatic assay | Same |
| General Device Characteristic Differences | | |
| Measuring Range | 0.3-120 μg/L | 0.1-120 μg/L |
| Instrument | DxI 9000 Access Immunoassay Analyzer | Access Immunoassay system |
| Substrate | Lumi-Phos PRO Substrate | Access Substrate |
# VI Standards/Guidance Documents Referenced:
Clinical & Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods
CLSI EP06-2nd Edition: Evaluation of the Linearity of Quantitative Measurement Procedures
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CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
CLSI EP09c-3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
1. Precision/Reproducibility:
Studies were performed to determine the imprecision of the candidate device using a protocol based on the CLSI EP05-A3 guideline.
The study was run on three DxI 9000 Access Immunoassay Analyzers using three reagent lots, and three calibrator lots. Pooled serum samples were tested in duplicates across two runs per day, over 20 days. Within-run (repeatability), between run, between day, and within-lab (total) precision results for a representative reagent lot on a single instrument are summarized below:
| Concentration (μg/L) | | | Repeatability (Within-run) | | Between-Run | | Between-Day | | Within-lab (Total) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Sample 1 | 80 | 1.8 | 0.1 | 4.6 | 0.01 | 0.8 | 0.0001 | 0.0 | 0.1 | 4.7 |
| Sample 2 | 80 | 9.1 | 0.3 | 3.3 | 0.2 | 2.0 | 0.2 | 1.7 | 0.4 | 4.1 |
| Sample 3 | 80 | 25 | 0.8 | 3.3 | 0.6 | 2.3 | 0.5 | 1.8 | 1.1 | 4.4 |
| Sample 4 | 80 | 38 | 1.4 | 3.6 | 0.8 | 2.1 | 0.4 | 1.0 | 1.6 | 4.3 |
| Sample 5 | 80 | 98 | 3.2 | 3.3 | 2.3 | 2.4 | 0.9 | 0.9 | 4.1 | 4.2 |
2. Linearity:
Studies were performed using serum samples across the assay measuring range to evaluate the linearity of the Access Ostase assay on the DxI 9000 Access Immunoassay Analyzer in accordance with the CLSI EP06-2nd Edition guideline. The data was analyzed using a weighted linear regression model.
The results of these linearity studies support that the Access Ostase assay is linear on the DxI 9000 Access Immunoassay Analyzer throughout the proposed measuring range of 0.3-120 $\mu \mathrm{g} / \mathrm{L}$ .
3. Analytical Specificity/Interference:
Interference was reviewed in K994278.
4. Assay Reportable Range:
See Linearity section VII A.2 above.
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability was reviewed in K994278.
6. Detection Limit:
Studies were performed to determine the Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) using protocols based on the CLSI EP17-A2 guideline. The LoB was determined to be 0.003 µg/L. The LoD was determined to be 0.007 µg/L. The LoQ was determined to be 0.3 µg/L based on a 20% CV performance goal.
7. Assay Cut-Off:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was conducted comparing the candidate device to the predicate device using a protocol based on the CLSI EP09c-A3 guideline. A total of one hundred and sixty-three (163) serum samples (153 were individual native serum, and 10 samples were native serum spiked with BAP) were evaluated in the method comparison study.
The study was run on three DxI 9000 instruments and three Access 2 instruments with three reagent pack lots and three calibrator lots.
The comparison between paired measurements was analyzed by fitting the observed Access Ostase Assay on the DxI 9000 instrument (dependent variable, y) into a Passing-Bablok regression model, with the observed Access Ostase Assay on Access 2 values as the only independent variable (x, predicate). The results are shown below:
| N | Concentration Range* (μg/L) | Slope (95 % CI) | Intercept (95% CI) | Correlation Coefficient (R) |
| --- | --- | --- | --- | --- |
| 163 | 0.34 – 108 | 0.95 (0.93, 0.98) | 0.53 (0.32,0.75) | 1.00 |
*Range is Access 2 values
2. Matrix Comparison:
Matrix comparison studies for serum and plasma (sodium heparin and lithium heparin) were reviewed in K994278.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
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2. Clinical Specificity:
Not applicable.
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:
The 'Expected values' are the same as claimed in K994278:
| | N | BAP Mean (μg/L) | SD | BAP Median (μg/L) | BAP 95th Percentile (μg/L) |
| --- | --- | --- | --- | --- | --- |
| Males | 217 | 12.3 | 4.3 | 11.6 | 20.1 |
| Premenopausal Females | 228 | 8.7 | 2.9 | 8.5 | 14.3 |
| Postmenopausal Females | 529 | 13.2 | 4.7 | 12.5 | 22.4 |
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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