(210 days)
Not Found
No
The summary describes a standard immunoassay for measuring bone alkaline phosphatase and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay designed to measure a biomarker (BAP) to aid in the management of postmenopausal osteoporosis and Paget's disease, rather than directly treating or preventing a disease.
Yes
The device is described as an "immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP)... This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease," which directly indicates its role in diagnosing or aiding in the diagnosis and management of medical conditions.
No
The device description explicitly states it consists of a reagent pack, calibrators, QCs, substrate, and wash buffer, all designed for use with a specific hardware analyzer (Dxl 9000 Access Immunoassay Analyzer). This indicates it is a hardware-based immunoassay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of bone alkaline phosphatase (BAP)... in human serum and plasma." This indicates it's used to test samples taken from the human body.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and mentions "reagent pack, calibrators and QCs," which are typical components of in vitro diagnostic tests. It also specifies use with an "Immunoassay Analyzer in a clinical laboratory setting," further supporting its use in a diagnostic context.
- Clinical Laboratory Setting: The intended user/care setting is a "clinical laboratory setting," which is where IVD tests are performed.
N/A
Intended Use / 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.
Product codes
CIN
Device Description
The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A study based on CLSI EP09c, 3rd Edition using Passing Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
N: 163
Concentration Range (µg/L): 0.34 - 108 (Access 2 values)
Slope: 0.95 (95% CI: 0.93 - 0.98)
Intercept: 0.53 (95% CI: 0.32 - 0.75)
Correlation Coefficient R: 1.00
Imprecision: 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.
The assay was designed to have within-laboratory imprecision of ≤ 0.2 µg/L SD at concentrations ≤ 3 µg/L and ≤ 7.0% CV at concentrations > 3 µg/L.
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): Claimed LoB is 0.1 ug/L on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): Claimed LoD is 0.1 µg/L on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): Claimed LoQ is 0.3 µg/L on Dxl 9000 Access Immunoassay Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2024
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K232904
Trade/Device Name: Access Ostase Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline Phosphatase or Isoenzymes Test System Regulatory Class: Class II Product Code: CIN Dated: March 1, 2024 Received: March 1, 2024
Dear Kate Oelberg:
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).
1
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 QS 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 (QS) 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,
Digitally signed by Thomas C. Thomas C. Miller -S Date: 2024.04.15 Miller -S 15:56:59 -04'00'
for Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232904
Device Name Access Ostase
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (k) Summary
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 K232904
Submitted Bv:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primarv Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberg@beckman.com
Alternate Contact:
Madhuri Boppana Regulatory Affairs Analyst, Senior Email: mboppana@beckman.com
Device Name
Common Name: Access Ostase Trade Name: Access Ostase Classification Name: Alkaline phosphatase or isoenzymes test system. Classification Regulation: [21 CFR 862.1050] Product Code: CIN
Predicate Device Device Name: Access Ostase 510(k) Numbers: K994278
Device Description
The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Intended 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.
4
| Parameter | Access Ostase on Access 2
Immunoassay System (Predicate) | Access Ostase on Dxl
9000 Access
Immunoassay System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended 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. | Same |
| Analyte
Measured | Bone alkaline phosphatase (BAP), an
indicator of osteoblastic activity, in
human serum and plasma | Same |
| Technology | One-step immunoenzymatic assay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum or plasma | Same |
| Measuring
Range | Approximately 0.1 – 120 μg/L | Approximately 0.3 – 120
μg/L |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos Pro Substrate |
Comparison of Technological Characteristics to the Predicate
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
5
CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples- Third Edition
Summary of Studies
Method Comparison: A study based on CLSI EP09c, 3rd Edition using Passing Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
| N | Concentration
Range*
(µg/L) | Slope | Slope
95% CI | Intercept | 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
Imprecision: The assay was designed to have within-laboratory imprecision as listed below:
• ≤ 0.2 µg/L SD at concentrations ≤ 3 µg/L
• ≤ 7.0% CV at concentrations > 3 µg/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.
| Concentration (µg/L) | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-
Laboratory | | |
|----------------------|----|-------------------------------|-----|-------------|------|-------------|--------|-----------------------|-----|-----|
| 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 |
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): The claimed LoB for Access Ostase assay is 0.1 ug/L on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The claimed LoD for Access Ostase assay is 0.1 µg/L on Dxl 9000 Access Immunoassay Analyzer.
6
Limit of Quantitation (LoQ): The claimed LoQ for Access Ostase assay is 0.3 µg/L on Dxl 9000 Access Immunoassay Analyzer.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access Ostase on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Ostase on the Access 2 Immunoassay System 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.