(65 days)
BioRad Quantaphase II Folate Radioassay
Not Found
No
The summary describes a standard in vitro diagnostic assay based on chemiluminescent technology and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the quantitative determination of folate to aid in diagnosis and treatment, not to directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia."
No
The device description clearly indicates it is a "Chemiluminescent Microparticle Folate Binding Protein assay," which is a laboratory test involving reagents and hardware (the ARCHITECT i System). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative determination of folate in human serum, plasma, and red blood cells" and that the measurements "aid in the diagnosis and treatment of megaloblastic anemia." This clearly indicates that the device is used to test samples taken from the human body to provide information for medical diagnosis.
- Device Description: The description details a "Chemiluminescent Microparticle Folate Binding Protein assay," which is a laboratory test method performed on biological samples.
- Performance Studies: The performance studies compare the device to a "BioRad Quantaphase II Folate Radioassay," which is another type of laboratory test for folate.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Abbott ARCHITECT™ Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.
Product codes
CGN, JIS, JJX
Device Description
The ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, (tripotassium EDTA, lithium heparin, or sodium heparin) and red blood cells (tripotassium EDTA). The ARCHITECT Folate assay is calibrated with Abbott ARCHITECT Folate Calibrators. Abbott ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
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
Substantial equivalence has been demonstrated between the ARCHITECT Folate assay and the BioRad Quantaphase II Folate Radioassay.
Sample: Serum, n: 333, Regression Method: Least Squares, r: 0.927, Slope (95%CI): 0.97 (0.92, 1.01), Intercept(95% CI): 0.44 (0.02, 0.87)
Sample: Serum, n: 333, Regression Method: Passing-Bablok, r: 0.927, Slope (95%CI): 1.08 (1.05, 1.12), Intercept(95% CI): -0.18 (-0.47, 0.06)
Sample: Whole Blood, n: 160, Regression Method: Least Squares, r: 0.929, Slope (95%CI): 1.00 (0.94, 1.06), Intercept(95% CI): 36.04 (4.62, 67.46)
Sample: Whole Blood, n: 160, Regression Method: Passing-Bablok, r: 0.929, Slope (95%CI): 1.14 (1.09, 1.20), Intercept(95% CI): -18.83 (-40.97, 3.59)
Key Metrics
Not Found
Predicate Device(s)
BioRad Quantaphase II Folate Radioassay.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
0
FEB 5 1999
510(k) Summary Abbott ARCHITECT™ Folate Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Folate constitutes data supporting a substantially equivalent determination.
The ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, (tripotassium EDTA, lithium heparin, or sodium heparin) and red blood cells (tripotassium EDTA). The ARCHITECT Folate assay is calibrated with Abbott ARCHITECT Folate Calibrators. Abbott ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Substantial equivalence has been demonstrated between the ARCHITECT Folate assay and the BioRad Quantaphase II Folate Radioassay. The intended use of the ARCHITECT Folate assay is for the quantitative determination of folate in human serum, plasma, and red blood cells. The intended use of the BioRad Quantaphase II Folate Radioassay is for the quantitative determination of folate in human serum, plasma, and whole blood.
| Sample | Regression Method | n | r | Slope (95%CI) | Intercept(95% CI) |
|---|---|---|---|---|---|
| Serum | Least Squares | 333 | 0.927 | 0.97 (0.92, 1.01) | 0.44 (0.02, 0.87) |
| Passing-Bablok | 333 | 0.927 | 1.08 (1.05, 1.12) | -0.18 (-0.47, 0.06) | |
| Whole Blood | Least Squares | 160 | 0.929 | 1.00 (0.94, 1.06) | 36.04 (4.62, 67.46) |
| Passing-Bablok | 160 | 0.929 | 1.14 (1.09, 1.20) | -18.83 (-40.97, 3.59) |
In conclusion, these data demonstrate that the ARCHITECT Folate assay is as safe and effective as, and is substantially equivalent to, the BioRad Quantaphase II Folate Radioassay.
1
Prepared and Submitted December 1, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092
产品
.
Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537
CHITBCT Folats 510(k)
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The text is slightly slanted.
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
FEB 5 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Laura L. Granitz Senior Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostic Division Dept. 9V6 Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064
| Re: | K984301 | ||
|---|---|---|---|
| Trade Name: | Abbott ARCHITECT™ Folate | ||
| Regulatory Class: | II | Product Code: | CGN |
| II | JIS | ||
| I | JJX | ||
| Dated: | January 20, 1999 | ||
| Received: | January 21, 1999 |
Dear Ms. Granitz:
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.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Sutman
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
4
510(k) Number (if known): 498430 l Device Name: Abbott ARCHITECT™ Folate
Indications For Use:
The Abbott ARCHITECT™ Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluanon/(ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984301
Prescription Use
(Per 21 CFR 801.109)
(Qptional Format 1-2-96)
OR
Over-The-Counter Use__