(140 days)
No
The summary describes a standard immunoassay using competitive binding and a calibration curve. There is no mention of AI/ML in the device description, performance studies, or key metrics. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an in vitro diagnostic (IVD) assay designed to detect folate levels for diagnostic purposes related to anemia, not to treat or directly manage a condition in a patient.
Yes
The "Intended Use / Indications for Use" section states: "Folic acid measurements are used in the diagnosis and treatment of anemias." This explicitly indicates the device's role in diagnosis.
No
The device description clearly indicates a binding assay using reagents and intended for use on immunoassay analyzers, which are hardware devices. The summary describes performance studies related to the assay itself and its performance on the analyzers, not standalone software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Binding assay for the in vitro quantitative determination of folate in human serum." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The assay is performed on "human serum," which is a biological sample taken from the body, a common characteristic of IVDs.
- Purpose: The assay is used for "quantitative determination of folate," which is a measurement of a substance in a biological sample for diagnostic purposes ("used in the diagnosis and treatment of anemias").
- Device Description: The description details a "competitive test principle" using reagents to analyze the sample, which is typical of laboratory-based diagnostic tests.
- Performance Studies: The document includes performance studies like precision, analytical specificity, reference range, and method comparison, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
All 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 human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.
Product codes
CGN
Device Description
The Folate III 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 FBP (labeled with a ruthenium complex).
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) 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)
Precision
Predicate Device: Roche Elecsys Folate III (K082340) Labeled Performance Characteristics
_cobas e 411:
Within-run Sample Mean SD CV HS 1 4.30 0.157 3.7% HS 2 6.17 0.274 4.4% HS 3 6.83 0.288 4.2% HS 4 15.7 0.620 4.0% PCV1 4.05 0.235 5.8% PCV2 11.8 0.562 4.8%
Total Sample Mean SD CV HS 1 4.30 0.383 8.9% HS 2 6.17 0.444 7.2% HS 3 6.83 0.484 7.1% HS 4 15.7 0.956 6.1% PCV1 4.05 0.382 9.4% PCV2 11.8 0.845 7.2%
Candidate Device: Elecsys Folate III Assay Labeled Performance Characteristics
_cobas e 411:
Within-run (will be labeled Repeatability) Sample Mean SD CV HS 1 2.29 0.155 6.8% HS 2 3.92 0.200 5.1% HS 3 11.9 0.346 2.9% HS 4 13.4 0.301 2.2% HS 5 17.8 0.44 2.5% PCV1 3.24 0.215 6.6% PCV2 11.6 0.314 2.7%
Total (will be labeled Intermediate) Sample Mean SD CV HS 1 2.29 0.247 10.8% HS 2 3.92 0.318 8.1% HS 3 11.9 0.571 4.8% HS 4 13.4 0.574 4.3% HS 5 17.8 0.67 3.7% PCV1 3.24 0.309 9.5% PCV2 11.6 0.566 4.9%
Reference range study
Predicate Device: Roche Elecsys Folate III (K082340) Labeled Performance Characteristics
Country USA (N) 261 Median 31.8 nmol/L, 14.0 ng/mL 2.5th-97.5th percentile 16.6-59.3 nmol/L, 7.3-26.1 ng/mL
Candidate Device: Elecsys Folate III Assay
Country USA (N) 214 Median 26.8 nmol/L, 11.8 ng/mL 2.5th-97.5th percentile 10.9-54.9 nmol/L, 4.78-24.2 ng/mL
Method Comparison
Predicate Device: Abbott Architect Folate assay (K092740)
n = 106 Min = 2.08 ng/mL Max = 19.6 ng/mL
Passing/Bablok: Slope 0.980, Intercept -0.095, Tau/r 0.924, Bias at 4 ng/mL -0.175
Candidate Device: Elecsys Folate III Assay
n = 106 Min = 2.08 ng/mL Max = 19.6 ng/mL
Linear regression: Slope 0.976, Intercept 0.041, Tau/r 0.984, Bias at 4 ng/mL -0.054
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring Range
Predicate Device: 1.50- 20.0 ng/mL
Candidate Device: 2.0- 20.0 ng/mL
Analytical Sensitivity
Predicate Device:
Limit of Blank (LoB): = 0.640 ng/mL
Limit of Detection (LoD): = 1.50 ng/mL
Limit of Quantitation (LoQ): = 2.0 ng/mL
Candidate Device:
Limit of Blank (LoB): = 0.6 ng/mL
Limit of Detection (LoD): = 1.2 ng/mL
Limit of Quantitation (LoQ): = 2.0 ng/mL
Analytical Specificity
Predicate Device: Roche Elecsys Folate III (K082340) Labeled Performance Characteristics
Cross reactant: Amethopterin, concentration tested (ng/mL): 750, Highest cross-reactivity observed (%): 2.3
Cross reactant: Aminopterin, concentration tested (ng/mL): 750, Highest cross-reactivity observed (%): 2.7
Cross reactant: Folonic acid, concentration tested (ng/mL): 750, Highest cross-reactivity observed (%): 2.3
Candidate Device: Elecsys Folate III Assay Labeled Performance Characteristics
Cross reactant: Amethopterin, concentration tested (ng/mL): 1500, Highest cross-reactivity observed (%): 2.5
Cross reactant: Aminopterin, concentration tested (ng/mL): 1500, Highest cross-reactivity observed (%): 4.4
Cross reactant: Folonic acid, concentration tested (ng/mL): 1500, Highest cross-reactivity observed (%): 0.7
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are connected by a curved line that runs from the top of the head of the top profile to the bottom of the chin of the bottom profile. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
ROCHE DIAGNOSTICS KELLI TÜRNER U.S. REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416
Re: K141426
Trade/Device Name: Elecsys Folate III Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: II Product Code: CGN Dated: September 10, 2014 Received: September 11, 2014
Dear Ms. Turner:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141426
Device Name Elecsys Folate III
Indications for Use (Describe)
Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary for the Elecsys Folate III 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
9115 Hague Road
P.O. Box 50416
Indianapolis, IN 46250-0415 | | |
| | Contact Person: Kelli Turner | | |
| | • | Phone: (317) 521-4515 | |
| | • | Fax: (317) 521-2324 | |
| | • | Email: kelli.turner@roche.com | |
| | Date Prepared: October 9, 2014 | | |
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits
official notification as required by Section 510(k) of the Federal Food, Drug
and Cosmetics Act of our intention to market the device described in this
Premarket Notification [510(k)]. | | |
| | The purpose of this premarket notification is to obtain FDA review and
clearance for the Folate III Assay. | | |
| Device Name | Proprietary name: | Elecsys Folate III Assay | |
| | Common name: | Folate III assay | |
| | Classification name: | Acid, Folic, Radioassay | |
| | Product Code: | CGN | |
| | Predicate Device: | Roche Elecsys Folate III (K082340) | |
| Establishment
Registration | For the Elecsys Folate III assay, the establishment registration number for
Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for
Penzberg, Germany, is 9610529. The establishment registration number for
Roche Diagnostics in the United States is 1823260 | | |
| Classification | The FDA has classified the Radiometry, Folate III assay as a Class II device. | | |
| Device
Description | The Folate III 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 FBP (labeled with a
ruthenium complex).
Results are determined using a calibration curve that is generated specifically on
each instrument by a 2 point calibration and a master curve (5-point-calibration)
provided with the reagent bar code. | | |
| | Reagents-working
solutions | Description | Volume |
| | PT1: Pretreatment
reagent 1 | Sodium 2-mercaptoethanesulfonate
(MESNA) 40 g/L, pH 5.5 | 4 mL |
| | PT2: Pretreatment
reagent 2 | Sodium hydroxide 25 g/L | 5 mL |
| | M: Microparticle | Streptavidin-coated microparticles 0.72
mg/mL; preservative | 6.5 mL |
| | R1: Folate binding | Ruthenium labeled folate binding protein | 9 mL |
4
protein
R2: Folate~biotin
510(k) Summary for Elecsys Folate III Assay, continued
75 µg/mL; human serum albumin (stabilizer); borate/phosphate/citrate buffer 70 mmol/L, pH 5.5; preservative
Biotinylated folate 17 µg/L; biotin 120
borate buffer 100 mmol/L, pH 9.0;
preservative
µg/L; human serum albumin (stabilizer);
Continued on next page
8 mL
5
| Intended | Elecsys Folate III: | ||
|---|---|---|---|
| Use/ | Binding assay for the in vitro quantitative determination of folate in | ||
| Indications | human serum. The binding assay is intended for use on Elecsys and | ||
| for Use | cobas e immunoassay analyzers. Folic acid measurements are used in | ||
| the diagnosis and treatment of anemias. | |||
| Substantial | |||
| Equivalence | The Elecsys Folate III assay is substantially equivalent to other devices | ||
| legally marketed in the United States. | |||
| The Elecsys Folate III assay is equivalent to Elecsys Folate III assay | |||
| (K082340). | |||
6
The following table compares the Elecsys Folate III Assay with its predicate Substantial device (K082340). Equivalence -Comparison
Comparison of Assays, Similarities and Differences
| Table 1 | |
|---|---|
| --------- | -- |
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Roche Elecsys | |
| Folate III (K082340) | Candidate Device: Elecsys Folate III Assay | |
| General Assay Features | ||
| Intended Use/ Indications for Use | Intended for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. | Same. |
| Assay Protocol | The Elecsys Folate 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 FBP (labeled with ruthenium). | Same. |
| Detection Protocol | Electrochemiluminescent Assay | Same. |
| Applications | 27-minute application | Same. |
| Instrument Platform | Elecsys and cobas e immunoassay analyzers. | Same. |
| Sample Volume | 25 μL | Same |
| Sample Type | Human serum. | Same. |
7
Comparison of Assays—Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Roche Elecsys | |
| Folate III (K082340) | Candidate Device: Elecsys Folate | |
| III Assay | ||
| General Assay Features | ||
| Reagents | Competition principle. Total duration | |
| of assay: 27 minutes | Same. | |
| Calibrator | Elecsys Folate III CalSet | Same. |
| Calibration | ||
| Interval | 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). Renewed calibration is | ||
| recommended as follows: | ||
| cobas e 411 analyzers: | ||
| • 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 specified limits | Same. | |
| Controls | Elecsys PreciControl Varia | Same. |
| Traceability | ||
| /Standardization | Standardized against the Elecsys | |
| Folate II assay (K043318) | Standardized against WHO | |
| International Standard NIBSC code: | ||
| 03/178. |
8
Comparison of Assays—Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||||||
|---|---|---|---|---|---|---|
| Feature | Predicate Device: Roche Elecsys Folate III (K082340) | Candidate Device: Elecsys Folate III Assay | ||||
| General Assay Features | ||||||
| Reagent | ||||||
| Stability | Unopened: | |||||
| 2-8°C - Up to the stated expiration date | ||||||
| Opened 2-8°C - 8 weeks | ||||||
| On Analyzers – 2 weeks or 4 weeks | ||||||
| when stored alternatively in the | ||||||
| refrigerator and on the analyzer, with | ||||||
| the toal time on-board the analyzer | ||||||
| not exceeding 10x8 hours | Same. | |||||
| Measuring | ||||||
| Range | 1.50- 20.0 ng/mL | 2.0- 20.0 ng/mL | ||||
| Analytical | ||||||
| Sensitivity | Limit of Blank (LoB): = 0.640 ng/mL | |||||
| Limit of Detection (LoD): = 1.50 ng/mL | ||||||
| Limit of Quantitation (LoQ): = 2.0 ng/mL | Limit of Blank (LoB): = 0.6 ng/mL | |||||
| Limit of Detection (LoD): = 1.2 ng/mL | ||||||
| Limit of Quantitation (LoQ): = 2.0 ng/mL | ||||||
| Analytical | ||||||
| Specificity | Cross reactant | concentration tested (ng/mL) | Highest cross-reactivity observed (%) | Cross reactant | concentration tested (ng/mL) | Highest cross-reactivity observed (%) |
| Amethopterin | 750 | 2.3 | Amethopterin | 1500 | 2.5 | |
| Aminopterin | 750 | 2.7 | Aminopterin | 1500 | 4.4 | |
| Folonic acid | 750 | 2.3 | Folonic acid | 1500 | 0.7 |
9
Comparison of Assays—Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | Predicate Device: Roche Elecsys | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Folate III (K082340) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeled Performance Characteristics | Candidate Device: Elecsys Folate III Assay | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeled Performance Characteristics | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Precision | cobas e 411: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Within-run Sample Mean SD CV HS 1 4.30 0.157 3.7% HS 2 6.17 0.274 4.4% HS 3 6.83 0.288 4.2% HS 4 15.7 0.620 4.0% PCV1 4.05 0.235 5.8% PCV2 11.8 0.562 4.8% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total Sample Mean SD CV HS 1 4.30 0.383 8.9% HS 2 6.17 0.444 7.2% HS 3 6.83 0.484 7.1% HS 4 15.7 0.956 6.1% PCV1 4.05 0.382 9.4% PCV2 11.8 0.845 7.2% | cobas e 411: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Within-run (will be labeled Repeatability) Sample Mean SD CV HS 1 2.29 0.155 6.8% HS 2 3.92 0.200 5.1% HS 3 11.9 0.346 2.9% HS 4 13.4 0.301 2.2% HS 5 17.8 0.44 2.5% PCV1 3.24 0.215 6.6% PCV2 11.6 0.314 2.7% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total (will be labeled Intermediate) Sample Mean SD CV HS 1 2.29 0.247 10.8% HS 2 3.92 0.318 8.1% HS 3 11.9 0.571 4.8% HS 4 13.4 0.574 4.3% HS 5 17.8 0.67 3.7% PCV1 3.24 0.309 9.5% PCV2 11.6 0.566 4.9% |
HS= Human Serum PCV1=PreciControl Varia level 1 PCV2=PreciControl Varia level 2
10
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Roche Elecsys | |
| Folate III (K082340) |
Candidate Device: Elecsys Folate III Assay | |
| Labeled Performance Characteristics | | |
| Limitations | The assay is unaffected by:
Bilirubin