(417 days)
Not Found
No
The summary describes a standard immunoassay for measuring EPO levels and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay used for the quantitative determination of erythropoietin levels, intended as an aid in diagnosis and monitoring, not for direct treatment of a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended as an aid in the diagnosis of anemias and polycythemias." It also mentions that it "may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias."
No
The device description explicitly states it consists of a reagent pack and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of erythropoietin levels in human serum and plasma" and is "intended as an aid in the diagnosis of anemias and polycythemias." This clearly indicates it's used to test samples taken from the human body to provide information for medical diagnosis.
- Device Description: It describes the components as a "reagent pack and calibrators," which are typical components of in vitro diagnostic assays.
- Performance Studies: The document details performance studies like precision, analytical sensitivity, dilution recovery, and methods comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The inclusion of predicate devices with K numbers (which are FDA premarket notification numbers for medical devices, including IVDs) further confirms its classification as a medical device, specifically an IVD given the context.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
GGT, JIT
Device Description
The Access® EPO assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the Access substrate and wash buffers.
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)
Precision: The assay exhibits total precision of ≤ 10% CV at EPO concentrations > 3mlU/mL. Assay precision was tested at concentrations from approximately 9 to 475 mIU/mL. The within-run imprecision ranged from 1.8% CV to 8.7% CV. Total imprecision ranged from 2.6% CV to 8.7% CV.
Analytical Sensitivity: The lowest detectable level of EPO distinguishable from zero (Access EPO Calibrator S0) is ≤0.6 mIU/mL.
Dilution Recovery (Linearity); Dilution recovery studies were performed by diluting multiple human serum and plasma (heparin) samples at various levels with Access EPO Calibrator SO. Sample mean recovery values for all serum and plasma samples, were within the range of 100 ± 15%.
Methods Comparison: Internal and external site comparison studies run with both the Access EPO and RDS Quantikine ELISA assays demonstrated acceptable agreement and the following statistical data.
Internal Site Study: Slope of 1.0511, intercept of -1.3595, and correlation coefficient (r) of 0.988. For this study N=103 with an EPO concentration range of approximately 3 to 182 mIU/mL.
External Site Study: Slope of 1.1216, intercept of -2.4168, and correlation coefficient (r) of 0.995. For this study N=113 with an EPO concentration range of approximately 3 to 193 mIU/mL.
Analytical Specificity: There was no significant interference from therapeutic drugs or similar compounds in the Access EPO assay. In addition, there was no significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides).
Stability: EPO reagents are stable for 28 days after opening and calibrators are stable for 90 days after opening. The calibration curve is stable for 28 days.
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.
K936016, K983203, K980737, K992799
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
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
0
OCT -6 2006
| Applicant: | Beckman Coulter, Inc.
Immunodiagnostics Development Center
1000 Lake Hazeltine Drive
Chaska, MN 55318 | | Page 1 of 2
Date Prepared: October 4, 2006 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------|
| Contact Person: | Lynn Weist, Staff Regulatory Specialist | | |
| Trade Name: | Access® EPO Assay | | |
| Product Classification
and Code: | Device Class - II
Classification Code - GGT (EPO Assay) and JIT (Calibrators) | | |
| Predicate Devices: | K936016 - Quantikine IVD Erythropoietin ELISA Kit - R & D Systems, Inc.
K983203- IMMULITE EPO - Diagnostic Products Corp.
K980737 - Nichols Advantage Chemiluminescent Erythropoietin Immunoassay - Nichols
Institute Diagnostics
K992799 - Sangui Bio Tech, Inc. EPO [Erythropoietin] ELISA Kit | | |
| Device Description: | The Access® EPO assay consists of the reagent pack and calibrators. Other items needed
to perform the assay include the Access substrate and wash buffers. | | |
| Intended Use: | The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the
quantitative determination of erythropoietin levels in human serum and plasma (heparin)
using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis
of anemias and polycythemias. With the advent of the administration of recombinant
erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay
may be used also to aid in the prediction and monitoring of response to recombinant
erythropoietin treatment in persons with anemias.
The Access EPO calibrators are intended to calibrate the Access EPO assay for the
quantitative determination of EPO levels in human serum and plasma (heparin) using the
Access Immunoassay Systems. | | |
Comparison of Technological
Characteristics:
:
| Attribute | Access EPO | R&D Systems | DPC | Nichols | Sangui Bio Tech |
|---|---|---|---|---|---|
| Assay Type / | |||||
| Format | 2-site | ||||
| simultaneous | |||||
| immunometric | |||||
| (sandwich) | |||||
| chemiluminescent | ELISA | 2-site sequential | |||
| enzyme | |||||
| immunometric | |||||
| (sandwich) | |||||
| chemiluminescent | 2-site simultaneous | ||||
| immunometric | |||||
| (sandwich) | |||||
| chemiluminescent | 2-site simultaneous | ||||
| immunometric | |||||
| (sandwich) assay | |||||
| (ELISA) | |||||
| Composition | Paramagnetic | ||||
| particles coated | |||||
| with goat anti- | |||||
| mouse IgG: | |||||
| mouse anti- | |||||
| recombinant | |||||
| human EPO | |||||
| monoclonal | |||||
| antibody, BSA, | |||||
| sodium azide and | |||||
| ProClin 300. | |||||
| Chicken anti- | |||||
| recombinant | |||||
| mouse EPO | |||||
| alkaline | Microplate - | ||||
| polystyrene | |||||
| microplate coated | |||||
| with mouse | |||||
| monoclonal | |||||
| antibody against | |||||
| recombinant | |||||
| human EPO. | |||||
| Conjugate - anti- | |||||
| EPO polyclonal | |||||
| (rabbit) antibody: | |||||
| horseradish | |||||
| peroxidase | |||||
| conjugate w/ | |||||
| thimerosal as a | Solid phase - | ||||
| Polystyrene bead | |||||
| coated with an | |||||
| anti-ligand derived | |||||
| from streptavidin. | |||||
| Reagent - ligand- | |||||
| labeled murine | |||||
| monoclonal anti- | |||||
| EPO antibody with | |||||
| preservative. | |||||
| Alkaline | |||||
| phosphatase | |||||
| conjugated to goat | |||||
| polyclonal anti- | Streptavidin coated | ||||
| magnetic particles | |||||
| in a buffer | |||||
| containing goat, | |||||
| rabbit and mouse | |||||
| gamma globulin | |||||
| with sodium azide | |||||
| and ProClin 300. | |||||
| Acridinium ester- | |||||
| labeled mouse | |||||
| monoclonal | |||||
| antibody to human | |||||
| EPO in a buffered | |||||
| protein solution with | |||||
| antimicrobial | Carboxyl-terminal | ||||
| mouse monoclonal | |||||
| antibody & an affinity | |||||
| purified region- | |||||
| restricted amino- | |||||
| terminal sheep | |||||
| antibody. Solid | |||||
| phase coated with | |||||
| avidin. Capture | |||||
| antibodies are | |||||
| coupled with biotin. | |||||
| Horseradish | |||||
| peroxidase labeled | |||||
| Tag antibody. |
Beckman Coulter, Inc. Abbreviated 510k: Access® EPO Assay and Calibrators
Response to FDA Request for Information (Verbal October 3, 2006) October 4, 2006
CONFIDENTIAL
Page 9 of 10
1
510(k) Summary
Comparison of Technological Characteristics: (continued)
| Attribute | Access EPO | R&D Systems | DPC | Nichols | Sangui Bio Tech |
|---|---|---|---|---|---|
| Composition | |||||
| (continued) | phosphatase | ||||
| (bovine) conjugate, | |||||
| BSA, sodium azide | |||||
| and ProClin 300. | |||||
| TRIS saline buffer | |||||
| containing BSA, | |||||
| proteins (chicken, | |||||
| bovine, mouse), | |||||
| sodium azide and | |||||
| ProClin 300 | preservative. | EPO antibody in | |||
| buffer, with | |||||
| preservative. | agents. Biotin | ||||
| labeled mouse | |||||
| monoclonal antibody | |||||
| to human EPO in a | |||||
| buffered protein | |||||
| solution, with | |||||
| sodium azide and | |||||
| ProClin 300. | agents. | ||||
| Measuring | |||||
| Range / | |||||
| Reportable | |||||
| Range | 0.6 - 750 mlU/mL | 0-200 mIU/mL | 0-200 mlU/mL | 5-700 mU/mL | Unknown |
| Standardization | WHO 2nd IRP | ||||
| 67/343 | WHO 2nd IRP | ||||
| 67/343 | WHO 2nd IRP | ||||
| 67/343 | WHO 1st IS 87/684 | Unknown |
Summary of Performance Studies:
Precision: The assay exhibits total precision of ≤ 10% CV at EPO concentrations > Assay precision was tested at concentrations from approximately 9 to 475 3mlU/mL. mIU/mL. The within-run imprecision ranged from 1.8% CV to 8.7% CV. Total imprecision ranged from 2.6% CV to 8.7% CV.
Analytical Sensitivity: The lowest detectable level of EPO distinguishable from zero (Access EPO Calibrator S0) is ≤0.6 mIU/mL.
Dilution Recovery (Linearity); Dilution recovery studies were performed by diluting multiple human serum and plasma (heparin) samples at various levels with Access EPO Calibrator Sample mean recovery values for all serum and plasma samples, were within the SO. range of 100 ± 15%.
Methods Comparison: Internal and external site comparison studies run with both the Access EPO and RDS Quantikine ELISA assays demonstrated acceptable agreement and the following statistical data.
Internal Site Study: Slope of 1.0511, intercept of -1.3595, and correlation coefficient (r) of 0.988. For this study N=103 with an EPO concentration range of approximately 3 to 182 mIU/mL.
External Site Study: Slope of 1.1216, intercept of -2.4168, and correlation coefficient (r) of 0.995. For this study N=113 with an EPO concentration range of approximately 3 to 193 mIU/mL.
Analytical Specificity: There was no significant interference from therapeutic drugs or similar compounds in the Access EPO assay. In addition, there was no significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides).
Stability: EPO reagents are stable for 28 days after opening and calibrators are stable for 90 days after opening. The calibration curve is stable for 28 days.
Conclusion:
The EPO Assay and EPO Calibrators on the Access Immunoassay Systems is substantially equivalent to the predicates for the measurement of EPO in human serum and plasma.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Lynn Weist Staff Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
K052223 Re:
Trade/Device Name: Access® EPO Assay Regulation Number: 21 CFR & 864.7250 Regulation Name: Erythropoietin Assay Regulatory Class: II Product Code: GGT, JIT Dated: August 30, 2006 Received: August 31, 2006
Dear Ms. Weist:
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 (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. 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.
OCT - 6 2006
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
3
Page 2 –
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobat Z. Beckerf
Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052223
Device Name: Access® EPO Assay
Indications for Use:
Access® EPO assay is a paramagnetic particle, The chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Robert Zietzke
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052223
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Beckman Coulter, Inc. Abbreviated 510k: Access® EPO Assay and Calibrators Response to FDA Request for Information, dated September 16, 2005 August 30, 2006
CONFIDENTIAL
Page 18 of 32