(178 days)
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No
The description details a standard chemiluminescent immunoassay (CMIA) technology for quantitative determination of folate. There is no mention of AI, ML, or any computational methods beyond standard signal processing for RLU measurement.
No
The device is used for the quantitative determination of folate in human serum and plasma for diagnosis and treatment of megaloblastic anemia, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states, "Folate measurements are used in the diagnosis and treatment of megaloblastic anemia." This clearly indicates that the device is intended for diagnostic purposes.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) technology involving reagents, reaction vessels, microparticles, and an optical system to measure relative light units (RLUs). This involves significant hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "quantitative determination of folate in human serum and plasma." This is a test performed on biological samples taken from the body.
- Purpose: The intended use also states that "Folate measurements are used in the diagnosis and treatment of megaloblastic anemia." This indicates the test is used for medical purposes related to diagnosis and treatment.
- Device Description: The "Device Description" details a laboratory assay process involving chemical reactions and measurement of relative light units (RLUs) from a biological sample (serum and plasma). This is characteristic of an in vitro diagnostic test.
- Calibrators and Controls: The mention of "ARCHITECT Folate Calibrators" and "ARCHITECT Folate Controls" further confirms its use in a laboratory setting for quantitative measurements, which is typical for IVDs.
All 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
Reagents: The ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT i System. Folate measurements are used in the diagnosis and treatment of megaloblastic anemia.
Calibrators: The ARCHITECT Folate Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
Controls: The ARCHITECT Folate Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
Product codes
CGN, JIT, JJX
Device Description
The ARCHITECT Folate assay is a two-step assay for the quantitative determination of folate in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Two pre-treatment steps mediate the release of folate from endogenous folate binding protein.
In Pre-Treatment Step 1, the sample and Pre-treatment Reagent 2 (Dithiothreitol or DTT) are aspirated and dispensed into a reaction vessel (RV). In Pre-Treatment Step 2, an aliquot of sample/Pre-Treatment Reagent 2 mixture is aspirated and dispensed into a second RV. Pre-Treatment Reagent 1 (potassium hydroxide or KOH) is then added. An aliquot of the pre-treated sample is transferred into a third RV, followed by the addition of Folate Binding Protein (FBP) coated paramagnetic microparticles and assay specific diluent. Folate present in the sample binds to the FBP coated microparticles. After washing, pteroic acid-acridinium labeled conjugate is added and binds to unoccupied sites on the FBP coated microparticles. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of folate in the sample and the RLUs detected by the ARCHITECT i optical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ARCHITECT Folate assay is substantially equivalent to the AxSYM Folate assay in terms of precision, linearity, interferences, and method comparison as demonstrated in the non-clinical performance data in this 510(k) submission.
The ARCHITECT Folate assay demonstrated substantially equivalent performance to the AxSYM Folate assay with correlation coefficients of 0.898 for serum samples. General bias in folate results between the two methods is due to the standardization differences listed in the Substantial Equivalence table. The predicate device utilizes standards based on gravimetric preparations of folic acid. The investigational assay has been standardized to accurately recover WHO Serum Folate International Standard.(IS) 03/178.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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.
0
k 092740
ARCHITECT Folate
510(k) Summary (Summary of Safety and Effectiveness)
MAR - 5 2010
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Name:
Darla Abańo, Sr. Regulatory Administrator Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9V6 AP6C-2 100 Abbott Park Road Abbott Park, IL 60064
Device Name:
Reagents:
Classification Name: Folic acid test system Trade Name: ARCHITECT Folate Common Name: Folate Governing Regulation: 862.1295 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CGN
Calibrators:
Classification Name: Calibrator, secondary Trade Name: ARCHITECT Folate Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
ARCHITECT Folate 510(k) Submission revised
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Controls:
Classification Name: Quality Control Material (assayed and unassayed) Trade Name: ARCHITECT Folate Controls (Low, Medium, and High) Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed:
Reagents predicate: AxSYM Folate (K972232) Calibrators predicate: AxSYM Folate (K972232) Controls predicate: AxSYM Folate (K972232)
Intended Use of Device:
The ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Description of Device:
The ARCHITECT Folate assay is a two-step assay for the quantitative determination of folate in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Two pre-treatment steps mediate the release of folate from endogenous folate binding protein.
In Pre-Treatment Step 1, the sample and Pre-treatment Reagent 2 (Dithiothreitol or DTT) are aspirated and dispensed into a reaction vessel (RV). In Pre-Treatment Step 2, an aliquot of sample/Pre-Treatment Reagent 2 mixture is aspirated and
ARCHITECT Folate 510(k) Submission revised
Page 2 of 3
2
dispensed into a second RV. Pre-Treatment Reagent 1 (potassium hydroxide or KOH) is then added. An aliquot of the pre-treated sample is transferred into a third RV, followed by the addition of Folate Binding Protein (FBP) coated paramagnetic microparticles and assay specific diluent. Folate present in the sample binds to the FBP coated microparticles. After washing, pteroic acid-acridinium labeled conjugate is added and binds to unoccupied sites on the FBP coated microparticles. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of folate in the sample and the RLUs detected by the ARCHITECT i optical system.
Comparison of Technological Characteristics:
The ARCHITECT Folate assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative determination of folate in human serum and plasma. The AxSYM Folate assay utilizes ion capture technology for the quantitative measurement of folate in human serum, plasma, and red blood cells (RBC).
Summary of Non-Clinical Performance:
The ARCHITECT Folate assay is substantially equivalent to the AxSYM Folate assay in terms of precision, linearity, interferences, and method comparison as demonstrated in the non-clinical performance data in this 510(k) submission.
The ARCHITECT Folate assay demonstrated substantially equivalent performance to the AxSYM Folate assay with correlation coefficients of 0.898 for serum samples. General bias in folate results between the two methods is due to the standardization differences listed in the Substantial Equivalence table. The predicate device utilizes standards based on gravimetric preparations of folic acid. The investigational assay has been standardized to accurately recover WHO Serum Folate International Standard.(IS) 03/178.
ARCHITECT Folate 510(k) Submission revised
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Abbott Laboratories c/o Darla Abano 100 Abbott Park Rd., Dept 09V6, Bldg. AP6C-2 Abbott Park, IL 60064
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAR 0 5 2010
K092740 Re:
Trade Name: ARCHITECT Folate Regulation Number: 21 CFR §862.1295 Regulation Name: Folate Regulatory Class: Class II Product Codes: CGN, JIT, JJX Dated: March 3, 2010 Received: March 4, 2010
Dear Ms. Abano:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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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 (301) 796-5450. 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 (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K092740
Device Name: ARCHITECT Folate
Indications for Use:
Reagents
The ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT i System. Folate measurements are used in the diagnosis and treatment of megaloblastic anemia.
Calibrators
The ARCHITECT Folate Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
Controls
The ARCHITECT Folate Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
Prescription Use X (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR 807 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)
Carol C Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092740
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