(68 days)
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.
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.
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. The study aimed to demonstrate its substantial equivalence to the legally marketed predicate device, the Bio-Rad Quantaphase II® B12/Folate Radioassay.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by achieving a strong correlation and acceptable slope and intercept values compared to the predicate device. The study demonstrates the correlation between the ARCHITECT Folate assay and the Bio-Rad Quantaphase II® B12/Folate Radioassay. While specific numerical acceptance criteria (e.g., minimum 'r' value, acceptable ranges for slope and intercept) are not explicitly stated, the reported values are presented as evidence of substantial equivalence.
| Sample | Regression Method | n | Acceptance Criteria (Implicit) | Reported Device Performance (r) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) |
|---|---|---|---|---|---|---|
| Serum | Least Squares | 241 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 0.93 | 1.4 |
| Passing-Bablok | 241 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.05 | -0.0 | |
| Whole Blood | Least Squares | 244 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.05 | -54.7 |
| Passing-Bablok | 244 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.10 | -69.9 |
Note: The implicit acceptance criteria are derived from the objective of demonstrating "substantial equivalence" through correlation analysis with a predicate device. Ideally, a slope close to 1 and an intercept close to 0 indicate good agreement. While the whole blood intercept values are large, correlation coefficients are identical.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Serum: 241 specimens
- Whole Blood: 244 specimens
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, whether retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This study does not involve expert readers establishing ground truth as it is a quantitative assay comparing to a predicate device. The "ground truth" is effectively the results obtained from the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is a comparison of two quantitative laboratory assays, not a diagnostic imaging study requiring expert adjudication. The comparison is based on numerical results from both assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a study comparing the performance of a new laboratory assay to a predicate assay, not an AI-assisted diagnostic imaging study involving human readers.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The correlation analysis directly measures the performance of the ARCHITECT Folate assay (algorithm only, without human-in-the-loop) against the predicate device. The assay itself is a standalone measurement system.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative folate measurements obtained from the legally marketed predicate device, the Bio-Rad Quantaphase II® B12/Folate Radioassay.
8. Sample Size for the Training Set
The provided information pertains to the performance study (test set) for substantial equivalence. It does not mention a separate "training set" for the ARCHITECT Folate assay, suggesting that the assay's methodology and calibration were established prior to this comparison study. For in vitro diagnostic devices, a training set often refers to samples used during the development and optimization of the assay's reagents, protocols, and instrument parameters, which is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with established ground truth in the manner of AI/machine learning studies is not described for this type of in vitro diagnostic assay comparison. The assay's development and calibration would have followed standard laboratory best practices and validation, likely using reference materials and characterized samples, but this information is not provided in the summary.
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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)
§ 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.