(32 days)
Not Found
No
The summary describes a standard immunoassay system and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No
The device is an in vitro diagnostic assay intended to aid in the diagnosis of pernicious anemia, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia."
No
The device description explicitly states that the system comprises reagents, calibrators, QC, and Access Immunoassay Analyzers (hardware). This is an in vitro diagnostic system that includes physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia." This statement directly identifies the device as being used outside of the body to examine specimens for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Access Intrinsic Factor Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Product codes
LIG, JJX, JIT
Device Description
The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.
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
Imprecision: Imprecision was tested for concentrations from approximately 1.1 to 14.2 AU/mL. The within run imprecision ranged from 1.3% CV to 1.5% CV. Between-run assay imprecision ranged from 4.4% CV to 5.1% CV. Total imprecision ranged from 4.6% CV to 5.3% CV.
Dilution Recovery (Linearity): Linearity studies performed by diluting serum patient samples at various levels with Access intrinsic Factor Ab S0 Calibrator show that serial dilutions transform a positive sample result to a negative sample result.
Methods Comparison: A comparison of 127 values using the Access Intrinsic Factor Ab assay and a commercially available radioimmunoassay kit gave the following statistical data: Negative agreement=100%, Positive agreement =96.4%, and Overall Agreement = 92.1%.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides). In addition, samples with vitamin B12 values of
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling a rounded shape with two curved lines running through it. To the right of the symbol is the text "BECKMAN" in bold, sans-serif font, stacked above the word "COULTER", also in bold, sans-serif font. The overall design is simple and professional.
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: K033603
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1383 Fax: (952) 368-7610 Contact: Valynda Machen
Date Prepared: November 14, 2003
Device Names
- Intrinsic Factor Ab, Intrinsic Factor Ab Calibrators, and Proprietary Name: Intrinsic Factor Ab QC on the Access® Immunoassay Systems
- Immunoassay for the detection of intrinsic factor antibody Common Name:
Classification Name: Vitamin B12 Test System
Predicate Device
DPC IFbAb
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
510(k) Number: K811927
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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the words "BECKMAN COULTER" on the right. The graphic is a black circle with two white curved lines inside. The words "BECKMAN" and "COULTER" are stacked on top of each other.
Device Description
The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.
Intended Use
The Access Intrinsic Factor Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
Comparison of Technological Characteristics
| Attribute | DPC IFbAb RIA | Access IFAb |
|---|---|---|
| Intended | ||
| Use | For the detection of intrinsic | |
| factor blocking antibody in | ||
| serum. | For the detection of intrinsic | |
| factor antibody in human | ||
| serum and plasma. | ||
| Assay | ||
| Principles | DPC's IF bAb procedure | |
| detects anti-intrinsic factor | ||
| blocking antibody in serum by | ||
| its effect on the vitamin B12- | ||
| binding capacity of the solid- | ||
| phase intrinsic factor binder. | Utilizes the binding of intrinsic | |
| factor antibody to alkaline | ||
| phosphatase enzyme | ||
| conjugated to intrinsic factor, | ||
| followed by a competitive | ||
| binding reaction with | ||
| monoclonal antibody coupled | ||
| to the solid phase. | ||
| Solid | ||
| Support | Microcrystalline cellulose | |
| particles | Paramagnetic particles | |
| Detection | ||
| System | Utilizes ⁵⁷ Cobalt labeled | |
| vitamin B12; Measures bound | ||
| radioactivity with a gamma | ||
| counter | Utilizes dioxetane-based | |
| chemiluminescent substrate; | ||
| Measures light production from | ||
| a chemiluminescent reaction | ||
| Calibrator | Single level negative reference | |
| of liquid pooled human serum | ||
| negative for intrinsic factor | ||
| blocking antibody. | Single level calibrator of liquid | |
| synthetic matrix with an | ||
| intrinsic factor antibody | ||
| concentration of 1.00 AU/ml. |
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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye or a leaf. To the right of the circle is the text "BECKMAN" in bold, followed by "COULTER" in a smaller, also bold font, stacked below the first word.
Summary of Analytical Studies
Imprecision: Imprecision was tested for concentrations from approximately 1.1 to 14.2 AU/mL. The within run imprecision ranged from 1.3% CV to 1.5% CV. Between-run assay imprecision ranged from 4.4% CV to 5.1% CV. Total imprecision ranged from 4.6% CV to 5.3% CV.
Dilution Recovery (Linearity): Linearity studies performed by diluting serum patient samples at various levels with Access intrinsic Factor Ab S0 Calibrator show that serial dilutions transform a positive sample result to a negative sample result.
Methods Comparison: A comparison of 127 values using the Access Intrinsic Factor Ab assay and a commercially available radioimmunoassay kit gave the following statistical data: Negative agreement=100%, Positive agreement =96.4%, and Overall Agreement = 92.1%.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides). In addition, samples with vitamin B12 values of Trade/Device Name: Intrinsic Factor Ab, Intrinsic Factor Ab Calibrators, and Intrinsic Factor Ab QC on the Access Immunoassay Systems Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: LIG; JJX, JIT Dated: November 14, 2003 Received: November 17, 2003
Dear Ms. Machen:
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 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).
5
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.
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K033603
Intrinsic Factor Ab, Intrinsic Factor Ab Calibrators, and Intrinsic Device Name: Factor Ab QC on the Access Immunoassay Systems
Indications For Use:
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson & Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K033603 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The Counter Use | ________________ |
|---|---|
| ---------------------- | ------------------ |
(Optional Format 1-2-96)