(68 days)
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No
The summary describes a standard laboratory assay (Chemiluminescent Microparticle Folate Binding Protein assay) and its performance characteristics. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is used for diagnosis and monitoring of folate levels, not for directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia." This indicates that the device aids in determining a specific medical condition, which is the definition of a diagnostic device.
No
The device description clearly states it is a "Chemiluminescent Microparticle Folate Binding Protein assay," which is a laboratory test involving physical reagents and a system (ARCHITECT i System) to perform the analysis. This is not a software-only device.
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 folate in human serum, plasma, and red blood cells." This involves testing biological samples in vitro (outside the body).
- Purpose: The results are used "in the diagnosis and treatment of megaloblastic anemia," which is a medical condition. This aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or treatment.
- Device Description: It describes a "Chemiluminescent Microparticle Folate Binding Protein assay," which is a laboratory test method performed on biological samples.
- Sample Types: It specifies the use of "human serum, plasma, and red blood cells," which are biological specimens.
All these characteristics are consistent with the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Product codes
CGN, JIS, 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, and red blood cells. The ARCHITECT Folate assay is calibrated with ARCHITECT Folate Calibrators. ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Substantial equivalence has been demonstrated between the ARCHITECT Folate assay and the Bio-Rad Quantaphase II® B12/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 Bio-Rad Quantaphase II B12/Folate Radioassay is for the quantitative determination of folate in human serum, plasma, and whole blood. A correlation analysis between the two assays yielded the following results.
| Sample | Regression Method | n | r | Slope | Intercept |
|---|---|---|---|---|---|
| Serum | Least Squares | 241 | 0.904 | 0.93 | 1.4 |
| Passing-Bablok | 241 | 0.904 | 1.05 | -0.0 | |
| Whole Blood | Least Squares | 244 | 0.904 | 1.05 | -54.7 |
| Passing-Bablok | 244 | 0.904 | 1.10 | -69.9 |
n = number of specimens
r = correlation coefficient
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) Summary Abbott ARCHITECT® Folate
K02397
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, and red blood cells. The ARCHITECT Folate assay is calibrated with ARCHITECT Folate Calibrators. 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 Bio-Rad Quantaphase II® B12/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 Bio-Rad Quantaphase II B12/Folate Radioassay is for the quantitative determination of folate in human serum, plasma, and whole blood. A correlation analysis between the two assays yielded the following results.
| Sample | Regression Method | n | r | Slope | Intercept |
|---|---|---|---|---|---|
| Serum | Least Squares | 241 | 0.904 | 0.93 | 1.4 |
| Passing-Bablok | 241 | 0.904 | 1.05 | -0.0 | |
| Whole Blood | Least Squares | 244 | 0.904 | 1.05 | -54.7 |
| Passing-Bablok | 244 | 0.904 | 1.10 | -69.9 |
n = number of specimens
r = correlation coefficient
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In conclusion, these data demonstrate that the ARCHITECT Folate assay is as safe and effective as, and is substantially equivalent to, the Bio-Rad Quantaphase II B12/Folate Radioassay.
Prepared and Submitted October 4, 2002 by:
Margarett Durocher 10/4/02
Margaret Prochniak, M Senior Regulatory Specialist ADD Regulatory Affairs Phone: (847) 937-4106 Fax: (847) 937-9616 E-mail: Margaret.Prochniak@abbott.com
Abbott Laboratories Diagnostics Division Department 9V6, Building AP 34-2 200 Abbott Park Road Abbott Park, IL 60064-6187
ARCHITECT Folate 510(k) September 2002 ARCHITECT Folate 510(k).doc
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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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 2098 Gaither Road
Rockville MD 20850
1 6 2002
Ms. Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept 9V6, Bldg. AP34-2 200 Abbott Park Road Abbott, IL 60064-6187
K023397 Re: Trade/Device Name: Abbott ARCHITECT® Folate Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN; JIS; JIS; JJX Dated: October 4, 2002 Received: October 9, 2002
Dear Ms. Prochniak:
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).
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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). Other general information on your responsibilities under the Act may be obtained 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 Sutman
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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Applicant: Abbott Laboratories
23397 510(k) Number (if known): K
Abbott ARCHITECT® Folate Device Name:
Indications For Use:
The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023397
(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)