(140 days)
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.
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.
Roche Diagnostics' Elecsys Folate III Assay is a quantitative in vitro diagnostic device designed for measuring folate levels in human serum, primarily for the diagnosis and treatment of anemias. The following outlines its acceptance criteria and the studies performed to demonstrate its performance.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Folate III Assay are primarily established through comparison to a predicate device, the Roche Elecsys Folate III (K082340). The device demonstrates comparable or improved analytical performance characteristics.
| Feature | Predicate Device: Roche Elecsys Folate III (K082340) | Candidate Device: Elecsys Folate III Assay | Acceptance Criteria (Implied by equivalence) |
|---|---|---|---|
| Measuring Range | 1.50 - 20.0 ng/mL | 2.0 - 20.0 ng/mL | Similar or improved range |
| Analytical Sensitivity | |||
| Limit of Blank (LoB) | 0.640 ng/mL | 0.6 ng/mL | Equal to or lower than predicate |
| Limit of Detection (LoD) | 1.50 ng/mL | 1.2 ng/mL | Equal to or lower than predicate |
| Limit of Quantitation (LoQ) | 2.0 ng/mL | 2.0 ng/mL | Equal to or lower than predicate |
| Analytical Specificity (Cross-reactivity) | |||
| Amethopterin | 2.3% at 750 ng/mL | 2.5% at 1500 ng/mL | Comparable or improved |
| Aminopterin | 2.7% at 750 ng/mL | 4.4% at 1500 ng/mL | Comparable or improved |
| Folonic acid | 2.3% at 750 ng/mL | 0.7% at 1500 ng/mL | Comparable or improved |
| Precision (cobas e 411) | |||
| Within-run (Repeatability) | %CV range: 3.7% - 5.8% | %CV range: 2.2% - 6.8% | Comparable to predicate |
| Total (Intermediate) | %CV range: 6.1% - 9.4% | %CV range: 3.7% - 10.8% | Comparable to predicate |
| Limitations (Interference) | |||
| Bilirubin | unaffected < 33 mg/dL | unaffected < 29 mg/dL | Comparable |
| Lipemia | unaffected < 1500 mg/dL | unaffected < 1500 mg/dL | Comparable |
| Biotin | unaffected < 21 ng/mL | unaffected < 21 ng/mL | Comparable |
| Rheumatoid factors | unaffected < 1000 IU/mL | unaffected < 1000 IU/mL | Comparable |
| IgG | unaffected < 1.6 g/dL | unaffected < 1.6 g/dL | Comparable |
| IgA | unaffected < 0.4 g/dL | unaffected < 0.4 g/dL | Comparable |
| IgM | Not specified | unaffected < 1.0 g/dL | Comparable |
| Reference Range Study (USA) | |||
| Median | 31.8 nmol/L (14.0 ng/mL) | 26.8 nmol/L (11.8 ng/mL) | Established reference range |
| 2.5th-97.5th percentile | 16.6-59.3 nmol/L (7.3-26.1 ng/mL) | 10.9-54.9 nmol/L (4.78-24.2 ng/mL) | Established reference range |
| Method Comparison (vs. Abbott Architect Folate K092740) | Good correlation | ||
| Slope | - | Passing/Bablok: 0.980, Linear regression: 0.976 | Near 1.0 |
| Intercept | - | Passing/Bablok: -0.095, Linear regression: 0.041 | Near 0.0 |
| Tau/r | - | Passing/Bablok: 0.924, Linear regression: 0.984 | High value, indicating strong correlation |
Study Details
The provided document describes a premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device (Roche Elecsys Folate III, K082340). The studies conducted are analytical performance studies.
-
Sample sizes used for the test set and the data provenance:
- Precision (Repeatability/Intermediate): Human serum (HS) samples (5 levels) and PreciControl Varia (PCV) control levels (2 levels) were used. The document lists mean, SD, and CV values, which are derived from repeated measurements of these samples. The exact number of individual patient samples in the precision study is not explicitly stated, but typically these studies involve multiple runs over several days.
- Analytical Specificity (Cross-reactivity): Specific cross-reactants (Amethopterin, Aminopterin, Folonic acid) were tested at concentrations of 1500 ng/mL.
- Limitations (Interference): Bilirubin (< 29 mg/dL), Lipemia (< 1500 mg/dL), Biotin (< 21 ng/mL), Rheumatoid factors (< 1000 IU/mL), IgG (< 1.6 g/dL), IgM (< 1.0 g/dL), IgA (< 0.4 g/dL) were tested. Also, 16 commonly used pharmaceuticals and human erythropoietin were tested. The number of samples for each interference test is not specified.
- Reference Range Study:
- Predicate Device: N = 261 subjects from USA.
- Candidate Device: N = 214 subjects from USA.
- Provenance: All reference range data is from the USA. These appear to be prospective studies to establish healthy reference ranges.
- Method Comparison: n = 106 patient samples were used, with folate concentrations ranging from 2.08 ng/mL to 19.6 ng/mL.
- Provenance: Not explicitly stated, but typically these are retrospective or prospectively collected clinical samples.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is an in vitro diagnostic (IVD) device for quantitative measurement of an analyte (folate). "Ground truth" in this context refers to the concentration of folate in the samples, determined by a reference method or the predicate device, rather than expert interpretation of images or clinical outcomes. Therefore, no "experts" in the sense of medical specialists reviewing results are mentioned as establishing ground truth. The ground truth for method comparison is the result obtained from the predicate device (Abbott Architect Folate assay, K092740). -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is an IVD device for quantitative measurement, not an assessment of diagnostic performance based on human interpretation or consensus. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an IVD device, not an AI-assisted diagnostic imaging device that involves human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance characteristics (e.g., precision, measuring range, analytical sensitivity, specificity) described are for the Elecsys Folate III Assay itself, operating as a standalone algorithm/device. The method comparison study directly compares the results of the candidate device with another established assay. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Performance: The ground truth for evaluating analytical performance parameters like LoB, LoD, LoQ, precision, and specificity is typically based on control materials, spiked samples, and established analytical methods.
- Method Comparison: The ground truth for the method comparison study was the results obtained from the predicate device, the Abbott Architect Folate assay (K092740). The acceptance criteria for this comparison would be for the candidate device's results to closely agree with those of the predicate.
- Reference Range: The reference range was established by testing samples from a healthy population in the USA (N=214).
-
The sample size for the training set:
The document does not specify a "training set" in the context of statistical modeling or machine learning. This is an immunoassay device, and its calibration curve is generated using a "2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code" (page 3). The master curve is based on internal validation data, but a specific "training set sample size" for model development is not provided. -
How the ground truth for the training set was established:
As above, the concept of a "training set" with established ground truth as in machine learning is not directly applicable to this immunoassay. The device's operational characteristics and performance are based on analytical validation following established guidelines (CLSI documents EP5-A2, EP17-A2, EP6-A, EP-09-A2-IR mentioned on page 12). The calibration curve, which is critical to the assay's function, is standardized with a master curve and a 2-point calibration, and the device is standardized against the WHO International Standard NIBSC code: 03/178 (page 7).
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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.
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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
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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)
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510(k) Summary for the Elecsys Folate III Assay
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ||
|---|---|---|---|
| SubmitterName,Address,Contact | Roche Diagnostics9115 Hague RoadP.O. Box 50416Indianapolis, 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 submitsofficial notification as required by Section 510(k) of the Federal Food, Drugand Cosmetics Act of our intention to market the device described in thisPremarket Notification [510(k)]. | ||
| The purpose of this premarket notification is to obtain FDA review andclearance 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) | ||
| EstablishmentRegistration | For the Elecsys Folate III assay, the establishment registration number forRoche Diagnostics GmbH in Mannheim, Germany, is 9610126 and forPenzberg, Germany, is 9610529. The establishment registration number forRoche Diagnostics in the United States is 1823260 | ||
| Classification | The FDA has classified the Radiometry, Folate III assay as a Class II device. | ||
| DeviceDescription | The Folate III Assay employs a competitive test principle using natural folatebinding protein (FBP) specific for folate. Folate in the sample competes with theadded folate (labeled with biotin) for the binding sites on FBP (labeled with aruthenium complex).Results are determined using a calibration curve that is generated specifically oneach instrument by a 2 point calibration and a master curve (5-point-calibration)provided with the reagent bar code. | ||
| Reagents-workingsolutions | Description | Volume | |
| PT1: Pretreatmentreagent 1 | Sodium 2-mercaptoethanesulfonate(MESNA) 40 g/L, pH 5.5 | 4 mL | |
| PT2: Pretreatmentreagent 2 | Sodium hydroxide 25 g/L | 5 mL | |
| M: Microparticle | Streptavidin-coated microparticles 0.72mg/mL; preservative | 6.5 mL | |
| R1: Folate binding | Ruthenium labeled folate binding protein | 9 mL |
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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
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| 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 inthe diagnosis and treatment of anemias. | ||
| SubstantialEquivalence | The Elecsys Folate III assay is substantially equivalent to other deviceslegally marketed in the United States. | ||
| The Elecsys Folate III assay is equivalent to Elecsys Folate III assay(K082340). | |||
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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 ElecsysFolate 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. |
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Comparison of Assays—Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Roche ElecsysFolate III (K082340) | Candidate Device: Elecsys FolateIII Assay |
| General Assay Features | ||
| Reagents | Competition principle. Total durationof assay: 27 minutes | Same. |
| Calibrator | Elecsys Folate III CalSet | Same. |
| CalibrationInterval | Calibration must be performed onceper reagent lot using fresh reagent (i.e.not more than 24 hours since thereagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:cobas e 411 analyzers:• After 1 month (28 days) whenusing the same reagent lot.• After 7 days (when using thesame reagent kit on theanalyzer).As required: e.g. quality controlfindings outside the specified limits | Same. |
| Controls | Elecsys PreciControl Varia | Same. |
| Traceability/Standardization | Standardized against the ElecsysFolate II assay (K043318) | Standardized against WHOInternational Standard NIBSC code:03/178. |
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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 | ||||||
| ReagentStability | Unopened:2-8°C - Up to the stated expiration dateOpened 2-8°C - 8 weeksOn Analyzers – 2 weeks or 4 weekswhen stored alternatively in therefrigerator and on the analyzer, withthe toal time on-board the analyzernot exceeding 10x8 hours | Same. | ||||
| MeasuringRange | 1.50- 20.0 ng/mL | 2.0- 20.0 ng/mL | ||||
| AnalyticalSensitivity | Limit of Blank (LoB): = 0.640 ng/mLLimit of Detection (LoD): = 1.50 ng/mLLimit of Quantitation (LoQ): = 2.0 ng/mL | Limit of Blank (LoB): = 0.6 ng/mLLimit of Detection (LoD): = 1.2 ng/mLLimit of Quantitation (LoQ): = 2.0 ng/mL | ||||
| AnalyticalSpecificity | 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 |
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Comparison of Assays—Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | Predicate Device: Roche ElecsysFolate III (K082340)Labeled Performance Characteristics | Candidate Device: Elecsys Folate III AssayLabeled 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
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Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Roche ElecsysFolate III (K082340)Candidate Device: Elecsys Folate III Assay | |
| Labeled Performance Characteristics | ||
| Limitations | The assay is unaffected by:Bilirubin < 33 mg/dL Lipemia < 1500 mg/dL Biotin < 21 ng/mL Rheumatoid factors < 1000 IU/mL IgG < 1.6 g/dL IgA < 0.4 g/dL In vitro tests were performed on 18commonly used pharmaceuticals and inaddition on human erythropoeetin. Nointerference with the assay was found. Samples with extremely high totalprotein concentrations (e.g. patientssuffering from Waldenstrom'smacroglobulinemia) are not for use inthis assay. In rare cases, interference due toextremely high titers of antibodies toanalyte-specific antibodies, streptavidinor ruthenium can occur. These effectsare minimized by suitable test design. It is contraindicated to measure samplesof patients receiving therapy withcertain pharmaceuticals, e.g.methotrexate or leucovorin, because ofthe cross-reactivity of folate bindingprotein with these compounds. For diagnostic purposes, the results shouldalways be assessed in conjunction withRBC folate, the patient's medical history,clinical examination and other findings. | The assay is unaffected by:Bilirubin < 29 mg/dL Lipemia < 1500 mg/dL Biotin < 21 ng/mL Rheumatoid factors < 1000 IU/mL IgG < 1.6 g/dL IgM < 1.0 g/dL IgA < 0.4 g/dL In vitro tests were performed on 16commonly used pharmaceuticals and inaddition on human erythropoeetin. Nointerference with the assay was found. Samples with extremely high totalprotein concentrations (e.g. patientssuffering from Waldenstrom'smacroglobulinemia) are not for use inthis assay. In rare cases, interference due toextremely high titers of antibodies toanalyte-specific antibodies, streptavidinor ruthenium can occur. These effectsare minimized by suitable test design. It is contraindicated to measure samplesof patients receiving therapy withcertain pharmaceuticals, e.g.methotrexate or leucovorin, because ofthe cross-reactivity of folate bindingprotein with these compounds. For diagnostic purposes, the results shouldalways be assessed in conjunction withRBC folate, the patient's medical history,clinical examination and other findings. |
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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 | ||||
| Labeled Performance Characteristics | ||||||
| Reference range study | Country | (N) | Median | 2.5th-97.5th percentile | ||
| nmol/L | ng/mL | nmol/L | ng/mL | |||
| USA | 261 | 31.8 | 14.0 | 16.6-59.3 | 7.3-26.1 | |
| Country | (N) | Median | 2.5th-97.5th percentile | |||
| nmol/L | ng/mL | nmol/L | ng/mL | |||
| USA | 214 | 26.8 | 11.8 | 10.9-54.9 | 4.78-24.2 | |
| Feature | Predicate Device: Abbott Architect Folate assay (K092740) | Candidate Device: Elecsys Folate III Assay | ||||
| Method Comparison | n = 106Min = 2.08 ng/mLMax = 19.6 ng/mL | Passing/Bablok | Linear regression | |||
| Slope | 0.980 | 0.976 | ||||
| Intercept | -0.095 | 0.041 | ||||
| Tau/r | 0.924 | 0.984 | ||||
| Bias at 4 ng/mL | -0.175 | -0.054 |
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| Standard/GuidanceDocumentReference | In addition to FDA guidance regarding 510(k) submissions, the followingstandards were used for the performance studies. |
|---|---|
| Evaluation of Precision Performance of QuantitativeMeasurement Methods; Approved Guideline – Second Edition.CLSI document EP5-A2, Volume 24, No. 25, August 2004. | |
| Evaluation of Detection Capability for Clinical LaboratoryMeasurement Procedures; Approved Guideline- Second Edition.CLSI document EP17-A2, Volume 32, No. 8, June 2012 | |
| Evaluation of the Linearity of Quantitative MeasurementProcedures: A Statistical Approach; Approved Guideline. CLSIdocument EP6-A, Volume 23, No. 16, April 2003. | |
| Method Comparison and Bias Estimation Using Patient Samples;Approved Guideline; Approved Guideline. CLSI document EP-09-A2-IR, Volume 22, No. 19, September 2002 | |
| Conclusion | The submitted information in this premarket notification supports a |
substantial equivalence decision. The data supports a safe, effective device which performs as well as or better than the predicate device.
§ 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.