(99 days)
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No
The summary describes a standard immunoassay for measuring a specific biomarker and does not mention any AI or ML components.
No
The device is an immunoassay designed for quantitative measurement of bone alkaline phosphatase (BAP) as an aid in managing specific medical conditions, not for treating or curing them.
Yes
The device is described as an "aid in the management of postmenopausal osteoporosis and Paget's disease," which directly implies its use in diagnosing or monitoring these conditions.
No
The device description clearly states it is a paramagnetic particle, chemiluminescent immunoassay, which is a laboratory test method involving physical and chemical components, not solely software. It also mentions use with the "Access Immunoassay System," implying hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section 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 "Device Description" further confirms it's an immunoassay for measuring BAP in human serum and plasma.
- Aid in Management: The intended use also states it's an "aid in the management of postmenopausal osteoporosis and Paget's disease," which is a diagnostic purpose.
- Method Comparison: The "Summary of Performance Studies" includes a method comparison study against a predicate device (Tandem-R Ostase), which is a common practice for IVD submissions.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System 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 (comma separated list FDA assigned to the subject device)
CIN, JIS
Device Description
The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.
Mentions image processing
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
8.1 Method Comparison Study Results
Access Ostase vs. Tandem-R Ostase
Slope: 0.9756
Intercept: -0.5987
r: 0.9895
N: 172
Mean % Differences Between Access Ostase and Tandem-R Ostase
- Osteoporosis: N (# pairs) = 88, Mean %Difference* = -5.96%, Standard Deviation = 12.37%
- Paget's: N (# pairs) = 84, Mean %Difference* = -7.01%, Standard Deviation = 14.25%
- Mean % Difference = [(Access -Tandem )/(Access+ Tandem/2)) X 100
8.2 Imprecision Summary
The between-run %CV observed across the concentrations tested ranged from 3.3% to 5.9%. The within-run %CV observed across the concentrations tested ranged from 1.5% to 2.6%. The total %CV observed across the concentrations tested ranged from 3.6% to 6.4%.
8.3 Recovery and Specimen Dilution
The results of spike and recovery across 15 samples ranged from 89.9% to 95.3% with an average recovery of 92.4%.
The results for ten (10) samples in the dilution study ranged from 78.1% to 106.1% with an average recovery of 92.2%. Regression analysis of these data yielded slopes ranging from 0.9280 to 1.0075 with an overall average slope of 0.9682. Correlation coefficients (r) ranged from 0.9999 to 0.9983 with an overall average correlation coefficient of 0.9994.
8.4 Interfering Substances
The following substances and concentrations were evaluated for interference in the Access Ostase Assay. There is no significant interference from any of the substances tested at these concentrations.
- Acetaminophen: 35 mg/dL
- Ibuprofen: 40 mg/dL
- alendronate: 8 mg/dL
- Pamidronate: 18 mg/dL
- Aspirin: 50 mg/dL
- progesterone: 25 mg/dL
- bilirubin – unconjugated: 40 mg/dL
- conjugated: 20 mg/dL
- protein: 3.8 and 15.6 g/dL
- calcitonin-salmon: 112 IU/dL
- raloxifene: 12 mg/dL
- Calcium: 40 mg/dL
- risedronate: 6 mg/dL
- estrogen: 10 mg/dL
- triglycerides: 2000 mg/dL
- etidronate: 105 mg/dL
- vitamin D: 80,500 IU/dL
- hemoglobin: 500 mg/dL
In summary, there is no significant interference from any of the substances tested at the concentrations listed above.
8.5 Reactivity with Intestinal, Placental and Liver Alkaline Phosphatase lsoenzymes
In these studies, 100 U/L of intestinal alkaline phosphatase yielded a result of 1.8 µg/L in the Access Ostase Assay. 100 U/L of placental alkaline phosphatase activity yielded a result of 0.3 µg/L in the Access Ostase Assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SUMMARY OF SAFETY AND EFFECTIVENESS
1.0 SUBMITTED BY:
Jill Kull, RAC, Staff Regulatory Specialist Beckman Coulter Inc., 7330 Carroll Rd. / P.O. Box 269006, San Diego, CA 92196-9006 Telephone: (858) 621-4584 FAX: (858) 621-4752 e-mail: jfkull@beckman.com
2.0 DATE SUBMITTED:
March 14, 2000
DEVICE NAME(S) 3.0
- 3.1 Proprietary Names Access® Ostase® Assay on the Access Immunoassay Analyzer 3.2
- Classification Names Bone alkaline phosphatase (BAP) test system.
PREDICATE DEVICE 4.0
| Beckman Coulter
Product | Predicate | Predicate Company | Docket
Number |
|----------------------------|----------------------------|-----------------------|------------------|
| Access® Ostase®
Assay | Tandem®-R
Ostase® Assay | Beckman Coulter, Inc. | K961573 |
5.0 DESCRIPTION OF THE DEVICE
The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.
Beckman Coulter Inc., Section 510(k) Notification Access® Ostase® Assay - K994278 Additional Information
Page 26
1
6.0 INTENDED USE OF THE DEVICE
This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
7.0 COMPARISON TO THE PREDICATE
| Technological
Characteristic | Access Ostase | Tandem-R
Ostase
(Predicate) |
|---------------------------------|--------------------------------------------------------------------------------|-----------------------------------|
| Analyte
Measured | Human bone alkaline phosphatase | Same |
| Intended Use | Aid in the management of
postmenopausal osteoporosis and
Paget's disease | Same |
| Solid Phase
Antibody | Monoclonal antibody to BAP | Same |
| Specimen Matrix | Human serum and plasma | Human serum |
| Assay Signal | Enzymetric/
Luminometer | Radiometric/
Gamma Counter |
| Assay Solid
Phase | Magnetic particles | Bead |
| System Method | Automated | Manual |
2
8.0 SUMMARY OF PERFORMANCE DATA
8.1 Method Comparison Study Results
Access Ostase vs. Tandem-R Ostase
| Slope | Intercept | r | N |
|---|---|---|---|
| 0.9756 | -0.5987 | 0.9895 | 172 |
Mean % Differences Between Access Ostase and Tandem-R Ostase
| Populations | N
(# pairs) | Mean
%Difference* | Standard
Deviation |
|--------------|----------------|----------------------|-----------------------|
| Osteoporosis | 88 | -5.96% | 12.37% |
| Paget's | 84 | -7.01% | 14.25% |
- Mean % Difference = [(Access -Tandem )/(Access+ Tandem/2)) X 100
8.2 Imprecision Summary
The between-run %CV observed across the concentrations tested ranged from 3.3% to 5.9%. The within-run %CV observed across the concentrations tested ranged from 1.5% to 2.6%. The total %CV observed across the concentrations tested ranged from 3.6% to 6.4%.
8.3 Recovery and Specimen Dilution
The results of spike and recovery across 15 samples ranged from 89.9% to 95.3% with an average recovery of 92.4%.
The results for ten (10) samples in the dilution study ranged from 78.1% to 106.1% with an average recovery of 92.2%. Regression analysis of these data yielded slopes ranging from 0.9280 to 1.0075 with an overall average slope of 0.9682. Correlation coefficients (r) ranged from 0.9999 to 0.9983 with an overall average correlation coefficient of 0.9994.
3
8.4 Interfering Substances
The following substances and concentrations were evaluated for interference in the Access Ostase Assay. There is no significant interference from any of the substances tested at these concentrations.
| Substance | Concentration
Tested | Substance | Concentration
Tested |
|-------------------------------------------|-------------------------|---------------|-------------------------|
| Acetaminophen | 35 mg/dL | Ibuprofen | 40 mg/dL |
| alendronate | 8 mg/dL | Pamidronate | 18 mg/dL |
| Aspirin | 50 mg/dL | progesterone | 25 mg/dL |
| bilirubin –
unconjugated
conjugated | 40 mg/dL
20 mg/dL | protein | 3.8 and
15.6 g/dL |
| calcitonin-salmon | 112 IU/dL | raloxifene | 12 mg/dL |
| Calcium | 40 mg/dL | risedronate | 6 mg/dL |
| estrogen | 10 mg/dL | triglycerides | 2000 mg/dL |
| etidronate | 105 mg/dL | vitamin D | 80,500 IU/dL |
| hemoglobin | 500 mg/dL | | |
In summary, there is no significant interference from any of the substances tested at the concentrations listed above.
- 8.5 Reactivity with Intestinal, Placental and Liver Alkaline Phosphatase lsoenzymes
In these studies, 100 U/L of intestinal alkaline phosphatase yielded a result of 1.8 µg/L in the Access Ostase Assay. 100 U/L of placental alkaline phosphatase activity yielded a result of 0.3 µg/L in the Access Ostase Assay.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
4
- Question 4. Please add a statement at the beginning of the clinical trial section indicating that all the clinical trials were performed with the Tandem-R.
- The following statement was added to page 5 (page 95 of the original Answer: submission) of the directional insert.
CLINICAL STUDIES
In the following section the studies were generated using the Tandem-R Ostase Assay.
Question 5: Please send a copy of the revised labeling for the File.
Answer: A copy of the revised directional insert is attached.
5
Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three birds in flight, arranged in a row.
MAR 28 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jill Kull, RAC Staff Regulatory Specialist Beckman Coulter, Inc. 7330 Carroll Road P.O. Box 269006 San Diego, California 92196-9006
K994278 Re: Trade Name: Access® Ostase® Assay Regulatory Class: II Product Code: CIN, JIS Dated: March 14, 2000 Received: March 15, 2000
Dear Ms. Kull:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENTS
510(k) Number (if known): Not yot assigned
Access® Ostase® Assay Device Name:
Indications for Use:
Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System 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.
21 CFR 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.
Division of Clinical Laboratory Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
Beckman Coulter Inc., Section 510(k) Notification Access® Ostase® Assay AccessOstase\Section_1.doc
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