(30 days)
Not Found
No
The summary describes a chemical reagent and an immunoassay analyzer for quantitative determination of folate. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is used for the quantitative determination of folate in erythrocytes and human serum, which aids in the diagnosis and treatment of anemias, but it does not directly treat a condition or deliver therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this devices are used in the diagnosis and treatment of anemias."
No
The device description clearly states it is a "reagent" and an "ascorbic acid solution," which are physical components, not software. It is used in conjunction with immunoassay analyzers, which are also hardware.
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 device is used for the "quantitative determination of folate in erythrocytes (RBC folate)" and that "Measurements obtained by this devices are used in the diagnosis and treatment of anemias." This clearly indicates that the device is intended for use in vitro (outside the body) to analyze a human sample (blood) for diagnostic purposes.
- Device Description: The description details how the reagent is used to prepare a blood sample for analysis, further supporting its role in an in vitro diagnostic process.
- Binding Assay: The mention of a "Binding assay for the in vitro quantitative determination of folate in human serum" also points to an in vitro diagnostic method.
- Predicate Device: The listed predicate device is also an "Elecsys Red Blood Cell Folate Lysing Reagent," which is consistent with an IVD product.
N/A
Intended Use / Indications for Use
Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate II assay for the quantitative determination of folate in erythrocytes (RBC folate).
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 RBC Folate Hemolyzing Reagent is an ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate II assay.
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)
Comparison of device performance to predicate device:
- Stability Ascorbic Acid: 14 days (predicate: 7 days)
- Whole blood at room temp: 2 hours (predicate: 4 hours), 1 day (predicate: 1 day)
- Hemolysate at room temp: 3.5 hours (predicate: not recommended)
- Expected Values: (US) N=105, 342 - 786 ng/ml; (Europe) N=282, 176 - 589 ng/ml (predicate: N=111, 342 - 786 ng/ml)
- Precision: Modified NCCLS (N=63) Whole blood 2010 analyzer 6.8% CV @ 478 ng/ml, 6.6% CV @ 573 ng/ml, 5.5% CV @ 623 ng/ml; E170 analyzer 9.5% CV @ 188 ng/ml, 6.1% CV @ 312 ng/ml, 3.6% CV @ 410 ng/ml (predicate: Modified NCCLS (N=60) Whole blood 2010 analyzer 6.5% CV @ 469 ng/ml, 4.8% CV @ 850 ng/ml)
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
Ko5/292
JUN 1 7 2005
510(k) Summary – Elecsys RBC Folate Hemolyzing Reagent
| 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: May 17, 2005 |
| Device Name | Proprietary name: Elecsys RBC Folate Hemolyzing Reagent |
| | Common name: Folate Assay |
| | Classification name: Acid, Folic, Radioimmunoassay |
| Device
description | The Elecsys RBC Folate Hemolyzing Reagent is an ascorbic acid solution
with which whole blood treated with anticoagulants (heparin or EDTA) is
diluted. After incubation the erythrocytes are lysed and intracellular folate is
liberated and stabilized. The hemolysate is then used as a prediluted sample
for subsequent measurement in the Elecsys Folate II assay. |
| Intended use | Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys
Folate II assay for the quantitative determination of folate in erythrocytes
(RBC folate). |
| Predicate
Device | We claim substantial equivalence to the Elecsys Red Blood Cell Folate
Lysing Reagent currently marketed on the Elecsys 2010 and MODULAR
ANALYTICS E170. (K981931). |
:
1
510(k) Summary – Elecsys RBC Folate Hemolyzing Reagent, continued
Device Comparison The table below illustrates the similarities between the Elecsys Red Blood Cell Folate Lysing Reagent (K981931) and the Elecsys RBC Folate Hemolyzing Reagent (modified device).
| Topic | Elecsys Red Blood Cell Folate
Lysing Reagent (K981931) | Elecsys RBC Folate Hemolyzing
Reagent (Modified Device) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Red Blood Cell Folate
Lysing Reagent to be used in combination
with the Elecsys Folate Assay for the
quanitation of folate in human red blood
cells. | Elecsys RBC Folate Hemolyzing Reagent
is used together with the Elecsys Folate II
assay for the quantitative determination of
folate in erythrocytes (RBC folate). |
| Test Principle | Competitive chemiluminescence | Same |
| Sample Type | Whole blood, heparinized or EDTA | Same |
| Sample / Lysing
Reagent Ratio | 1:31 | Same |
| Measuring range | Not provided | Without considering the hematocrit value:
up to 1407 nmol/L (620 ng/mL) |
| Pretreatment
incubation | 90 minutes ± 15 | Same |
| Stability
Ascorbic Acid | 7 days | 14 days |
| Whole blood at -
room temp | 4 hours
1 day | 2 hours
Same |
| Hemolysate at
- room temp | not recommended | 3.5 hours |
| Expected Values | N=111, 342 - 786 ng/ml | (US) N=105, 342 - 786 ng/ml
(Europe) N=282, 176 - 589 ng/ml |
| Precision | Modified NCCLS (N=60) Whole blood
2010 analyzer
6.5% CV @ 469 ng/ml
4.8% CV @ 850 ng/ml | Modified NCCLS (N=63) Whole blood
2010 analyzer
6.8% CV @ 478 ng/ml
6.6% CV @ 573 ng/ml
5.5% CV @ 623 ng/ml
E170 analyzer
9.5% CV @ 188 ng/ml
6.1% CV @ 312 ng/ml
3.6% CV @ 410 ng/ml |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
JUN 17 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kay A. Taylor MT(ASCP), RAC Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250
K051292 Re:
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: May 17, 2005 Received: May 18, 2005
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined 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 conninered prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that as nevice, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general voltable provided ing, 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 it may be subject to back dational denal 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 I lease of acrised that I Drimination that your device complies with other requirements of the Act that I Dr Hab Intact and regulations administered by other Federal agencies. You must or any I each 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 CFR Part 807), tacemis 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) I me letter will and it your te 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 (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 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
12051292 510(k) Number (if known):
Device Name: Roche Elecsys Folate II Immunoassay
Indications For Use:
Binding assay for the in vitro quantitative determination of folate in human serum. Dinding assurements 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.
Prescription Use XX : (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
signature
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Division Slan-C
Office of In Vitro Diaan Device Evaluation
510(k) K051292
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