(266 days)
No
The summary describes a standard immunoassay and its performance characteristics, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic (IVD) assay used to determine folate levels, which aids in the diagnosis and treatment of anemia. It does not provide therapy or treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Folate measurements are used in the diagnosis and treatment of anemia." This indicates the device's purpose is to aid in the diagnosis of a medical condition.
No
The device is described as a binding assay (reagent kit) intended for use on specific immunoassay analyzers (hardware). It involves chemical reactions and sample preparation steps, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC)." This indicates the device is used to test samples taken from the human body outside of the body.
- Indications for Use: The indications for use state that "Folate measurements are used in the diagnosis and treatment of anemia." This confirms the device is used for medical purposes related to diagnosis and treatment.
- Device Description: The description details a "binding assay" and an "electrochemiluminescence immunoassay 'ECLIA'" which are laboratory techniques used for in vitro testing. It also describes the process of preparing a sample (hemolysate) from whole blood, which is a common step in in vitro diagnostic procedures.
- Performance Studies: The document describes various performance studies (precision, linearity, interference, method comparison) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K103716) and name (Roche Diagnostics Elecsys Folate RBC) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, often through a 510(k) process where it is compared to a previously cleared device.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Product codes
CGN
Device Description
Elecsys Folate III is a binding assay that makes use of a competitive test principle using a ruthenium labeled folate-binding assay.
Elecsys Folate III is a binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Whole blood treated with anticoagulants (heparin or EDTA) is mixed with ascorbic acid solution and incubated for approximately 90 minutes at 20-25 °C. Lysis of the erythrocytes takes place, with liberation and stabilization of the intracellular folate. The resulting hemolysate sample is then used for subsequent measurement.
Results are determined via a calibration curve, which is instrument-specifically generated by 2point calibration, and a master curve provided via the cobas link.
Mentions image processing
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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
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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)
Non-clinical Performance Evaluation:
- Precision: Repeatability and Intermediate Precision according to CLSI guideline EP05-A3. All predefined acceptance criteria were met. Lot-to-lot Reproducibility evaluated using three reagent lots, all predefined acceptance criteria were met.
- Analytical Sensitivity: Limit of Blank (LoB) determined according to CLSI EP17-A2 to be 45 ng/mL. Limit of Detection (LoD) determined according to CLSI EP17-A2 to be 70 ng/mL. Limit of Quantitation (LoQ) determined according to CLSI EP17-A2 to be 120 ng/mL.
- Linearity and Dilution: Linearity assessed according to CLSI EP06-Ed2, study design B, using weighted linear regression analysis with at least seven concentrations of hemolysate samples. Linearity confirmed for measuring range of 120 - 620 ng/mL. Dilution study performed using high concentration hemolysate samples diluted 1:2. Data support instruction for use.
- Endogenous Interferences: Evaluated for Bilirubin (≤ 29 mg/dL), Intralipid (≤ 1500 mg/dL), Biotin (≤ 1200 ng/mL), Rheumatoid factors (≤ 1000 IU/mL), IgG (≤ 1.6 g/dL), IgA (≤ 0.4 g/dL), IgM (≤ 1 g/dL). All predefined acceptance criteria were met.
- Analytical Specificity/Cross-Reactivity: Evaluated Amethopterin (1.7%), Aminopterin (2.0%), Folinic acid (2.6%) at 750 ng/mL.
- Exogenous Interferences: Evaluated 17 commonly and 1 specially used pharmaceutical (erythropoietin) compounds. No interference found.
- Sample Matrix Comparison: Evaluated effect of Na-Heparin and K3-EDTA anticoagulants. Results within specification, supporting use of hemolysate from whole blood treated with these anticoagulants.
- Method Comparison to Predicate: Comparison with Elecsys Folate RBC (K103716) using 119 samples.
- Passing/Bablok: y = 1.04x - 14.6, τ = 0.913
- Linear regression: y = 1.03x - 11.0, r = 0.991
- Sample concentrations were between 132 and 618 ng/mL.
- Reagent Stability: On-board reagent stability for up to 16 weeks on cobas e 801 analyzer.
- Calibration Stability: Lot calibration recommended every 12 weeks. On-board calibration stability for up to 28 days without new calibration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Roche Diagnostics Elecsys Folate RBC (K103716)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 17, 2024
Roche Diagnostics Amy Pierce Regulatory Affairs Project Manager 9115 Hague Rd. P.O. Box 50416 Indianapolis, Indiana 46250
Re: K233060
Trade/Device Name: Elecys Folate III Regulation Number: 21 CFR 862.1295 Regulation Name: Folic Acid Test System Regulatory Class: Class II Product Code: CGN Dated: May 2, 2024 Received: May 2, 2024
Dear Amy Pierce:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233060
Device Name Elecsys Folate III
Indications for Use (Describe)
Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Elecsys Folate III 510(k) Summary- K233060
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Amy Pierce |
| Phone: 317-440-5108 | |
| Email: amy.pierce.ap2@roche.com | |
| Date Prepared | June 14, 2024 |
| Proprietary Name | Elecsys Folate III |
| Common Name | Folic acid test system |
| Classification Name | Acid, Folic, Radioimmunoassay |
| Product Codes, | |
| Regulation Numbers | CGN, 21 CFR 862.1295 |
| Predicate Devices | Roche Diagnostics Elecsys Folate RBC (K103716) |
| Establishment Registration | Roche Diagnostics GmbH Mannheim, Germany: 9610126 |
| Roche Diagnostics GmBH Penzberg, Germany: 9610529 | |
| Roche Diagnostics Indianapolis, IN United States: 1823260 |
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1. DEVICE DESCRIPTION
Elecsys Folate III is a binding assay that makes use of a competitive test principle using a ruthenium labeled folate-binding assay.
Elecsys Folate III is a binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Whole blood treated with anticoagulants (heparin or EDTA) is mixed with ascorbic acid solution and incubated for approximately 90 minutes at 20-25 °C. Lysis of the erythrocytes takes place, with liberation and stabilization of the intracellular folate. The resulting hemolysate sample is then used for subsequent measurement.
Results are determined via a calibration curve, which is instrument-specifically generated by 2point calibration, and a master curve provided via the cobas link.
1.1. Reagents
The reagent working solutions include cobas e pack (kit placed on the analyzer).
- PT1 Pretreatment reagent 1 .
- PT2 Pretreatment reagent 2 .
- M Streptavidin-coated microparticles, .
- R1 Folate-binding protein~Ru(bpy) .
- . R2 Folate~biotin, bis-tris propane buffer
2. INDICATIONS FOR USE
The following Indication for Use is for the Elecsys Folate III
Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The
5
electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
TECHNOLOGICAL CHARACTERISTICS 3.
The table below compares the Elecsys Folate III with its predicate device, Roche Elecsys Folate RBC (K103716).
| Item | Elecsys Folate RBC
(predicate device) | Elecsys Folate III
(candidate device) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This assay is used for the in vitro
quantitative determination of folate in
erythrocytes (red blood cells, RBC). The
electrochemiluminescence binding assay
is intended for use on Elecsys and cobas
e immunoassay analyzers. | Binding assay for the in vitro quantitative
determination of folate in erythrocytes (red
blood cells, RBC).
Folate measurements are used in the
diagnosis and treatment of anemia.
The electrochemiluminescence
immunoassay "ECLIA" is intended for use on
cobas e immunoassay analyzers. |
| Assay Method | Competitive | No change |
| Test type | Quantitative | No change |
| Application time | 27 min | No change |
| Handling of R1 and R2 | Liquid, ready to use | No change |
| Measuring range | 120-620 ng/mL | No change |
| Biotin tolerance | ≤ 21 ng/mL | ≤ 1200 ng/mL |
| Sample Anticoagulants | Whole blood treated with anticoagulants
Na-heparin or K3-EDTA | No change |
| Calibration Interval | Calibration frequency: Calibration must be
performed once per reagent lot using
fresh reagent (i.e. not more than 24 hours
since the reagent kit was registered on
the analyzer).
Calibration interval may be extended
based on acceptable verification of
calibration by the laboratory.
Renewed calibration is recommended as
follows:
• after 1 month (28 days) when using the
same reagent lot
• after 7 days (when using the same
reagent kit on the analyzer)
• as required: e.g. quality control findings
outside the defined limits | Calibration must be performed once per
reagent lot using fresh reagent (i.e. not more
than 24 hours since the cobas e pack was
registered on the analyzer).
Calibration interval may be extended based
on acceptable verification of calibration by
the laboratory.
Renewed calibration is recommended as
follows:
• after 12 weeks when using the same
reagent lot
• after 28 days when using the same cobas
e pack on the analyzer
• as required: e.g. quality control findings
outside the defined limits |
| Controls | Commercially available whole blood
control | No change |
| Item | Elecsys Folate RBC
(predicate device) | Elecsys Folate III
(candidate device) |
| Traceability/Standardization | This application has been standardized
against the Elecsys Folate III assay
(04476433190)/RBC application.
The standardization of the folate RBC
application includes the volume correction
to account for the preparation of
hemolysate sample (1:31 vol/vol). | No change |
| Reagent Stability | unopened at 2-8 °C: up to the stated
expiration date
after opening at 2-8 °C: 12 weeks
on analyzers: 2 weeks | unopened at 2-8 °C: up to the stated
expiration date
on analyzers: 2 weeks |
| Bilirubin tolerance |