(158 days)
Not Found
No
The summary describes a standard immunoassay for measuring sTfR levels and calculating an index. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on paramagnetic particles, chemiluminescence, and standard analytical methods.
No
Explanation: The device is an in-vitro diagnostic (IVD) assay intended to aid in the diagnosis of Iron Deficiency Anemia (IDA) and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD). It measures soluble transferrin receptor (sTfR) levels but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)". It also mentions the use of an sTfR/log ferritin index as "an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD." This directly indicates a diagnostic purpose.
No
The device description explicitly states that the device comprises reagents, calibrators, controls, and immunoassay analyzers, which are all hardware components. The software is part of the "Access Immunoassay Systems" but is not the sole component.
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 soluble transferrin receptor (sTfR) levels in human serum and plasma" and is "intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)." This clearly indicates it's used to test human samples in vitro to provide information for medical diagnosis.
- Device Description: The description details the components used to perform the test on human samples (reagent, calibrators, controls, and analyzers).
- Performance Studies: The document includes summaries of analytical and clinical studies performed on human samples to evaluate the device's performance in a diagnostic context.
- Predicate Device: The mention of a predicate device (Quantikine® IVD® sTfR ELISA) which is also an IVD further supports this classification.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with an Access Ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
Product codes (comma separated list FDA assigned to the subject device)
DDG, JIT, JJX
Device Description
The Access sTfR reagent, calibrators, controls, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of soluble transferrin receptor in human serum and plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Imprecision: Access sTfR exhibits total precision 9 nmol/L, and SD 0.04-0.22 nmol/L for samples with concentrations 9 nmol/L, and SD 0.08-0.38 nmol/L for samples with concentrations
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).
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AUG 1 1 2008
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.
The assigned 510(k) number is: K080634
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: 952-368-1271 Fax: (952) 368-7610 Contact: Lynn Weist
Date Prepared: June 5, 2008
Device Names
- Proprietary Name: sTfR, sTfR Calibrators, and sTfR QC on the Access® Immunoassay Systems
- Common Name: Immunological test for soluble transferrin receptor
Classification Name: Transferrin Immunological Test
:
Predicate Device
Quantikine® IVD® sTfR ELISA R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
510(k) Number: K970718
Device Description
The Access sTfR reagent, calibrators, controls, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of soluble transferrin receptor in human serum and plasma.
Beckman Coulter, Inc. Confidential
1
Access sTfR OIVD 510(k) Submission: 510(k) Summary
Intended Use
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access lmmunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with a ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
Comparison of Technological Characteristics
| Attribute | Quantikine IVD sTfR ELISA | Access sTfR |
|---|---|---|
| Intended | ||
| Use (Assay) | For the quantitative | |
| determination of soluble | ||
| transferrin receptor. | For the quantitative | |
| determination of soluble | ||
| transferrin receptor. May | ||
| also be used in conjunction | ||
| with a ferritin measurement to | ||
| provide a calculated sTfR/log | ||
| ferritin index. | ||
| Assay | ||
| Format | Two site, sandwich assay; | |
| Enzyme linked | ||
| immunosorbent assay | ||
| (ELISA) | Two site, sandwich assay; | |
| Sequential two-step | ||
| immunoenzymatic | ||
| chemiluminescent | ||
| immunoassay |
Beckman Coulter, Inc. Confidential
2
Access sTfR
OIVD 510(k) Submission: 510(k) Summary
| Attribute | Quantikine IVD sTfR ELISA | Access sTfR |
|---|---|---|
| Test System | Manual; Polystyrene microplate coated with mouse monoclonal antibody against sTfR | Automated; Paramagnetic particles coated with mouse monoclonal antibody against sTfR. Uses the same mouse monoclonal antibodies against sTfR in the capture phase and signal phase as the predicate device. |
| Detection System | Chromogenic reaction | Utilizes dioxetane-based chemiluminescent substrate; measures light production from a chemiluminescent reaction. |
| Calibrators | Calibrators are comprised of purified plasma sTfR at 6 levels (0, 3, 7, 20, 40, and 80 nmol/L) | Calibrators are comprised of natural sTfR at 6 levels (0, 3, 10, 30, 80, and 150 nmol/L) in a buffered matrix. |
| Controls | QCs are provided as lyophilized human sTfR at 3 levels (~7.5, ~20, ~50 nmol/L) in a buffered matrix. | QCs are human sTfR provided as a liquid at 3 levels (~10, ~25, ~90 nmol/L) in a buffered matrix. |
Beckman Coulter, Inc.
.
3
Summary of Analytical Studies
Imprecision: Access sTfR exhibits total precision ≤ 8% at concentrations greater than 9 nmol/L, and total SD 9 nmol/L, and SD 0.04-0.22 nmol/L for samples with concentrations ≤ 9 nmol/L. Total precision ranged from 2.6 to 5.4% CV for samples > 9 nmol/L, and SD 0.08-0.38 nmol/L for samples with concentrations ≤ 9 nmol/L.
Analytical Sensitivity: The lowest detectable level of soluble transferrin receptor distinguishable from zero (Access sTfR Calibrator S0) is Beckman Coulter, Inc. Confidential
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Image /page/5/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 or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 11 2008
Beckman Coulter, Inc. c/o Ms Lynn Weist Staff Regulatory Affairs Specialist 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K080634
Trade/Device Name: Access® sTfR, Access® sTfR Calibrators and Access® sTfR OC Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG, JIT, JJX Dated: July 29, 2008 Received: July 30, 2008
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.
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 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.
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); 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
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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m Chen
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K080634
Device Name: Access® sTfR, Access® sTfR Calibrators, Access® sTfR QC
Indications For Use:
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with an Access Ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria McChan
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080634