(21 days)
Not Found
No
The device description details a standard immunoassay with a competitive binding principle and chemiluminescent detection. There is no mention of AI or ML in the intended use, device description, or the specific sections checked for AI/ML terms. The calibration method is based on a standard curve and master curve, not AI/ML algorithms.
No
This device is an in vitro diagnostic (IVD) device used for measuring folate levels, which aids in the diagnosis and treatment of anemias. It does not directly treat a patient.
Yes
This device is a diagnostic device because its stated use is "in the diagnosis and treatment of anemias" and it measures folate levels in human serum, which are used for diagnostic purposes.
No
The device description clearly outlines a binding assay involving chemical reagents, microparticles, and an immunoassay analyzer (Roche Elecsys 2010/MODULAR ANALYTICS E170), indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is for the "in vitro quantitative determination of folate in human serum." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: It analyzes "human serum," which is a biological sample taken from a patient.
- Purpose: The measurements are used "in the diagnosis and treatment of anemias," indicating a medical purpose related to patient health.
- Device Description: The description details a laboratory-based assay using reagents and an analyzer to measure a substance in a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias.
The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) 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. In the first step, bound folate in the sample is released from endogenous folate binding proteins through incubation with pretreatment reagents. In the second step, ruthenium labeled folate binding protein complexes with the sample. In the third step, after the addition of streptavidin-coated microparticles and folate labeled with biotin, the unbound sites of the ruthenium labeled folate binding protein become occupied, with formation of a ruthenium labeled folate binding protein-folate biotin complex. The complex becomes bound to the solid phase. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
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
DEC 2 3 2004
510(k) Summary - Elecsys® Folate II
| 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
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3544 |
| | Contact person: Kay A. Taylor |
| | Date prepared: December 1, 2004 |
| Device Name | Proprietary name: Roche Elecsys® Folate II Immunoassay |
| | Common name: Folate Assay |
| | Classification name: Acid, Folic, Radioimmunoassay |
| Device
description | The Elecsys Folate II Assay employs a competitive test principle. In the first
step, bound folate in the sample is released from endogenous folate binding
proteins through incubation with pretreatment reagents. In the second step,
ruthenium labeled folate binding protein complexes with the sample. In the
third step, after the addition of streptavidin-coated microparticles and folate
labeled with biotin, the unbound sites of the ruthenium labeled folate binding
protein become occupied, with formation of a ruthenium labeled folate
binding protein-folate biotin complex. The complex becomes bound to the
solid phase. The reaction mixture is aspirated into the measuring cell where
the microparticles are magnetically captured onto the surface of the electrode,
unbound substances are removed. Voltage is applied to the electrode
inducing chemiluminescent emission which is measured by a photomultiplier.
Results are determined using a calibration curve that is generated specifically
on each instrument by a 2 point calibration and a master curve provided with
the reagent bar code. |
!
...
... ... ... ... ... ......................................................................................................................................................
1
510(k) Summary - Elecsys® Folate II, continued
| 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. |
|---|---|
| Predicate Device | We claim substantial equivalence to the Elecsys Folate II Immunoassay currently marketed on the MODULAR ANALYTICS E170. (K031756). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate II (K031756) and the Elecsys Folate II (modified device). |
| Topic | Elecsys® Folate II (K031756) | 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. | 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. | ||
| Indications for | ||
| Use | Measurements obtained by this | |
| devices are used in the diagnosis and | ||
| treatment of anemias of the | ||
| gastrointestinal malabsorption. | Measurements obtained by this | |
| devices are used in the diagnosis and | ||
| treatment of anemias | ||
| Test Principle | Competitive chemiluminescence | Same |
| Sample Type | Serum | Same |
| Expected | ||
| Values | 3.1-17.5 ng/ml | Same |
| Measuring | ||
| range | 0.600-20.00 ng/ml | Same |
:
, '
2
510(k) Summary - Elecsys® Folate II, continued
| Topic | Elecsys® Folate II
(K031756) | Elecsys® Folate II
(Modified Device) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Traceability | Standardized against Elecsys Folate
which was itself standardized against a
commercially available radiobinding
folate assay | Standardized against Elecsys Folate |
| Stability | Store at 2-8°C unopened up to the
expiration date. | Same |
| | Opened: | Opened: |
| | At 2-8°C for 12 weeks | Same |
| | On E170 / 2010 for 6 weeks | On E170 / 2010 for 1 week |
ﻴ
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines emanating from its head, representing the department's focus on health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2004
Ms. Kay A. Taylor MT (ASCP), RAC Regulatory Affairs Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Rd. PO Box 50457 Indianapolis, IN 46250-0457
Re: K043318
Trade/Device Name: Roche Elecsys Folate II Immunoassay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: December 1, 2004 Received: December 2, 2004
Dear Ms. Taylor:
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
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my Journe FDA finding of substantial equivalence of your device to a legally premaired 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 (240)276-0484. 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 Tou may obtain other general 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/industry/support/index.html
Sincerely yours,
Caul C. Benson for
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K043318
Device Name: Roche Elecsys Folate II Immunoassay
Indications For Use:
Binding assay for the in vitro quantitative determination of folate in human Measurements obtained by this devices are used in the diagnosis and serum. treatment of anemias.
The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Prescription Use XX (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 Benam
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safely
510(k) k0413318