(19 days)
Not Found
No
The summary describes a standard immunoassay using a competitive binding principle and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay used for the quantitative determination of folate in human serum, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states that "Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This directly indicates its role in diagnosis.
No
The device description clearly indicates a binding assay using reagents and intended for use on specific immunoassay analyzers, which are hardware components. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "in vitro quantitative determination of folate in human serum." This clearly indicates the device is used to test samples taken from the human body outside of the body.
- Purpose: The intended use also mentions that the measurements are "used in the diagnosis and treatment of anemias of gastrointestinal malabsorption." This confirms the device's role in providing information for medical diagnosis and treatment.
- Device Description: The description details a "binding assay" performed on "human serum," further supporting its use as an in vitro test.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The binding assay is intended for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CGN
Device Description
The Elecsys® Folate II Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate labeled with biotin for the binding sites on the ruthenium labeled FBP-complex.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 2 5 2003
510(k) Summary - Elecsys® Folate II Assay
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831 |
| | Contact person: Sherri L. Coenen |
| | Date prepared: June 6, 2003 |
| Device Name | Proprietary name: Elecsys® Folate II Assay |
| | Common name: Elecsys® Folate II Assay |
| | Classification name: Vitamin B12 Test System |
| Device
description | The Elecsys® Folate II Assay employs a competitive test principle using
natural folate binding protein (FBP) specific for folate. Folate in the sample
competes with the added folate labeled with biotin for the binding sites on the
ruthenium labeled FBP-complex. |
| Intended use | Binding assay for the in vitro quantitative determination of folate in human
serum. The binding assay is intended for use on the Roche Elecsys 2010 and
Modular Analytics E170 immunoassay analyzers. |
| Predicate
Device | We claim substantial equivalence to the currently marketed Elecsys® Folate
Assay. (K973674). |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
のお気になる。
continued
Reagent Summary
The following table describes the similarities and differences between the Elecsys® Folate II Assay and the predicate device.
| Topic | Elecsys® Folate
(K973674) | Elecsys® Folate II
(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Intended Use | Binding assay for the in vitro
quantitative determination of folate in
human serum. The binding assay is
intended for use on the Roche
Elecsys 2010 and Modular Analytics
E170 (Elecsys Module) immunoassay
analyzers. | Same |
| Method | competitive chemiluminescent
immunoassay | Same |
| Sample type | Human Serum | Same |
| Measuring
range | 0.600 - 20.00 ng/ml or
1.36 - 45.4 nmol/L | Same |
| Expected
values | 4.2 - 19.9 ng/ml | 3.1 - 17.5 ng/ml |
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Image /page/2/Picture/1 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 three human profiles facing right, with flowing lines suggesting movement or connection.
JUN 2 5 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K031756 Re:
Trade/Device Name: Elecsys® Folate II Assay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: June 3, 2003 Received: June 6, 2003
Dear Ms. Coenen:
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. Ilsting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
If vour 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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Page 2 –
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 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
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys® Folate II Assay
Indications For Use:
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
gastomicsema intracted for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.
(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) |
Alberto Suts
| Division Sign-Off | for Jean Cooper |
|---|---|
| ------------------- | ----------------- |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031756 |
|---|---|
| -------- | --------- |
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