(266 days)
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.
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.
Here's a summary of the acceptance criteria and study details for the Elecsys Folate III device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Precision | "All predefined acceptance criteria was met for the precision experiments." (Specific numerical criteria not explicitly stated in this document but implied to be within acceptable limits as per CLSI guideline EP05-A3.) | Repeatability (within-run precision) & Intermediate Precision (within-laboratory precision) (cobas e 801 analyzer) |
| Analytical Sensitivity | Based on CLSI EP17-A2 guidelines for Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ). | LoB: 45 ng/mL LoD: 70 ng/mL LoQ: 120 ng/mL |
| Linearity | Measurements across the claimed measuring range (120 - 620 ng/mL) must be linear as assessed per CLSI EP06-Ed2. | Linearity confirmed to support the measuring range of 120 - 620 ng/mL. |
| Dilution | Data must support instruction for use for samples diluted 1:2. | Data supports instruction for use. |
| Endogenous Interferences | "All predefined acceptance criteria were met" for various endogenous substances including Bilirubin, Intralipid, Biotin, Rheumatoid factors, IgG, IgA, IgM, at specified concentrations, confirming no significant interference. (Specific thresholds for non-interference not provided in text, but implied to be within acceptable limits). | No significant interference 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 |
| Analytical Specificity/Cross-Reactivity | Expected low cross-reactivity with specified compounds. (Specific thresholds for cross-reactivity not provided in text, but implied to be within acceptable limits). | Low cross-reactivity: Amethopterin: (750 ng/mL) 1.7% Aminopterin: (750 ng/mL) 2.0% Folinic acid: (750 ng/mL) 2.6% |
| Exogenous Interferences | No interference from 17 commonly used pharmaceuticals and erythropoietin. (Specific thresholds for non-interference not provided in text, but implied to be within acceptable limits). | No interference found from 17 commonly and 1 specially used pharmaceutical (erythropoietin) compounds. |
| Sample Matrix Comparison | Results within specification, supporting the use of hemolysate prepared from whole blood treated with Na-heparin or K3-EDTA. | Results were within specification and support the use of hemolysate prepared from whole blood and treated with Na-heparin or K3-EDTA. |
| Method Comparison to Predicate | High correlation and agreement with the predicate device (Elecsys Folate RBC). | Number of samples: 119 (concentrations 132-618 ng/mL) Passing/Bablok: y = 1.04x - 14.6, τ = 0.913 Linear regression: y = 1.03x - 11.0, r = 0.991 |
| Reagent Stability (On-board) | Reagent kits can be stored on-board for up to 16 weeks. | Tested on one cobas e 801 analyzer; Elecsys Folate III reagent kits can be stored on-board for up to 16 weeks. (Note: The product comparison table states "2 weeks" for predicate; this indicates an improvement for the candidate device.) |
| Calibration Stability (Lot) | Calibration for a lot is recommended every 12 weeks; during this period, fresh kits of same lot can be used without re-calibration using the day 0 curve. | Tested on one cobas e 801 analyzer. Calibration of an Elecsys Folate III reagent lot is recommended every 12 weeks. |
| Calibration Stability (On-board) | Reagent epacks can be stored on-board for up to 28 days without a new calibration. | Tested on one cobas e 801 analyzer. Elecsys Folate III epacks can be stored on board of the analyzers for up to 28 days without a new calibration. |
2. Sample Sizes and Data Provenance
- Precision (Repeatability & Intermediate Precision): Not explicitly stated, but typically involves multiple replicates over several days/runs with multiple instruments. Specific sample types are "Hemolysate 1" to "Hemolysate 5".
- Lot-to-lot Reproducibility: "three reagent lots" were used.
- Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, but determined according to CLSI EP17-A2, which involves specific numbers of blank and low-concentration samples.
- Linearity and Dilution: "At least seven concentrations using hemolysate samples" for linearity. Dilution study used "high concentration hemolysate samples".
- Endogenous Interferences: Not explicitly stated, but "various endogenous substances" were evaluated.
- Analytical Specificity/Cross-Reactivity: Not explicitly stated.
- Exogenous Interferences: "17 commonly and 1 specially used pharmaceutical" compounds.
- Sample Matrix Comparison: "Whole blood samples were drawn into Na-Heparin and K3-EDTA tubes." (Number not specified).
- Method Comparison to Predicate: 119 samples with concentrations between 132 and 618 ng/mL.
- Reagent Stability (On-board), Lot Calibration Stability, On-board Calibration Stability: Tested on "one cobas e 801 analyzer".
Data Provenance: The document states "NON-CLINICAL PERFORMANCE EVALUATION" and refers to CLSI (Clinical and Laboratory Standards Institute) guidelines, which are standard for in-vitro diagnostic device performance studies. The data is internal to Roche Diagnostics, a company with global operations. The specific country of origin for the studies is not stated, but given the submission is to the U.S. FDA, the studies are expected to meet international and U.S. regulatory standards. These are retrospective studies in the context of device development and validation.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is an in-vitro diagnostic (IVD) assay that produces quantitative measurements of folate. It does not involve human interpretation of images or other subjective data. Therefore, the "ground truth" for its performance is established by reference methods, calibrated standards, and accurate measurement principles, rather than human expert consensus. No human experts were used to establish ground truth in the way one would for an AI imaging device.
4. Adjudication Method (Test Set)
Not applicable, as this is an IVD device producing quantitative results, not an AI imaging device requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in-vitro diagnostic device, not an AI device assisting human readers with interpreting cases.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are standalone performance evaluations of the Elecsys Folate III assay (the "algorithm" in a broad sense for an IVD) without human intervention in the measurement process. The device performs the quantitative determination of folate using its defined binding assay and electrochemiluminescence immunoassay (ECLIA) method.
7. Type of Ground Truth Used
The ground truth for evaluating the Elecsys Folate III's performance is established through:
- Reference materials/standards: For analytical sensitivity (LoB, LoD, LoQ) and linearity, where known concentrations are used.
- Performance against a predicate method: For method comparison, the results are compared to a previously cleared, established method (Elecsys Folate RBC).
- CLSI guidelines: Adherence to established scientific and statistical methodologies for validating assay performance, implying well-defined benchmarks for accuracy, precision, and interference.
8. Sample Size for the Training Set
Not explicitly stated. For an IVD like the Elecsys Folate III, a traditional "training set" as understood in machine learning is not directly applicable. The "training" for such a system would involve the development and optimization of the reagent formulations, assay parameters, and calibration curve algorithms, using various samples and experiments during the research and development phase. However, a specific training set size with corresponding ground truths is not documented in the same way as an AI algorithm.
9. How the Ground Truth for the Training Set was Established
As above, a formal "training set ground truth" isn't directly applicable in the machine learning sense. The "ground truth" during the development and optimization (analogous to training) would have been established through:
- Known concentrations: Using purified folate standards or spiked samples.
- Reference methods: Comparing early-stage assay performance against established, often more labor-intensive or gold-standard methods for folate determination.
- Clinical correlation: (Though "clinical testing" is marked Not Applicable for this 510(k), early development might involve correlation with clinical status or outcomes).
- Statistical optimization: Adjusting reagent ratios, incubation times, and instrument settings to achieve optimal analytical performance characteristics (sensitivity, specificity, precision, linearity) based on these known values and reference method comparisons.
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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 RoadP.O. Box 50416Indianapolis, IN 46250-0457 |
| Contact | Amy PiercePhone: 317-440-5108Email: 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: 9610126Roche Diagnostics GmBH Penzberg, Germany: 9610529Roche 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
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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 vitroquantitative determination of folate inerythrocytes (red blood cells, RBC). Theelectrochemiluminescence binding assayis intended for use on Elecsys and cobase immunoassay analyzers. | Binding assay for the in vitro quantitativedetermination of folate in erythrocytes (redblood cells, RBC).Folate measurements are used in thediagnosis and treatment of anemia.The electrochemiluminescenceimmunoassay "ECLIA" is intended for use oncobas 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 anticoagulantsNa-heparin or K3-EDTA | No change |
| Calibration Interval | Calibration frequency: Calibration must beperformed once per reagent lot usingfresh reagent (i.e. not more than 24 hourssince the reagent kit was registered onthe analyzer).Calibration interval may be extendedbased on acceptable verification ofcalibration by the laboratory.Renewed calibration is recommended asfollows:• after 1 month (28 days) when using thesame reagent lot• after 7 days (when using the samereagent kit on the analyzer)• as required: e.g. quality control findingsoutside the defined limits | Calibration must be performed once perreagent lot using fresh reagent (i.e. not morethan 24 hours since the cobas e pack wasregistered on the analyzer).Calibration interval may be extended basedon acceptable verification of calibration bythe laboratory.Renewed calibration is recommended asfollows:• after 12 weeks when using the samereagent lot• after 28 days when using the same cobase pack on the analyzer• as required: e.g. quality control findingsoutside the defined limits |
| Controls | Commercially available whole bloodcontrol | No change |
| Item | Elecsys Folate RBC(predicate device) | Elecsys Folate III(candidate device) |
| Traceability/Standardization | This application has been standardizedagainst the Elecsys Folate III assay(04476433190)/RBC application.The standardization of the folate RBCapplication includes the volume correctionto account for the preparation ofhemolysate sample (1:31 vol/vol). | No change |
| Reagent Stability | unopened at 2-8 °C: up to the statedexpiration dateafter opening at 2-8 °C: 12 weekson analyzers: 2 weeks | unopened at 2-8 °C: up to the statedexpiration dateon analyzers: 2 weeks |
| Bilirubin tolerance | < 33 mg/dL | ≤ 29 mg/dL |
| Commonly usedpharmaceuticals | 16 | 17 |
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NON-CLINICAL PERFORMANCE EVALUATION 4.
The following performance data are provided in support of the substantial equivalence determination. All performance specifications were met.
4.1. Precision
Repeatability and Intermediate Precision 4.1.1.
Precision measurements were conducted for the updated Elecsys Folate III to evaluate repeatability (within-run precision) and the intermediate precision (within-laboratory precision) according the CLSI guideline EP05-A3. All predefined acceptance criteria was met for the precision experiments.
| cobas e 801 analyzer | |||||
|---|---|---|---|---|---|
| Repeatability | Intermediate precision | ||||
| Sample | Meanng/mL | SDng/mL | CV% | SDng/mL | CV% |
| Hemolysate 1 | 152 | 5.73 | 3.8 | 6.17 | 4.1 |
| Hemolysate 2 | 206 | 6.14 | 3.0 | 7.17 | 3.5 |
| Hemolysate 3 | 252 | 6.70 | 2.7 | 8.28 | 3.3 |
| Hemolysate 4 | 363 | 8.01 | 2.2 | 10.0 | 2.8 |
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| cobas e 801 analyzer | |||||
|---|---|---|---|---|---|
| Repeatability | Intermediate precision | ||||
| Sample | Meanng/mL | SDng/mL | CV% | SDng/mL | CV% |
| Hemolysate 5 | 605 | 10.7 | 1.8 | 14.6 | 2.4 |
Lot-to-lot Reproducibility 4.1.2.
Precision measurements were conducted according to CLSI guideline EP05-A3 to evaluate Lotto-Lot Reproducibility using three reagent lots. All predefined acceptance criteria was met for the lot-to-lot reproducibility experiment.
Analytical Sensitivity 4.2.
The Limit of Blank (LoB) was determined according to CLSI EP17-A2. The LoB claim in the labeling will be set to 45 ng/mL.
The Limit of Detection (LoD) was determined according to CLSI EP17-A2. The LoD claim in the labeling will be set to 70 ng/mL.
The Limit of Quantitation (LoQ) was determined according to CLSI EP17-A2. The LoQ claim in the labeling will be set to 120 ng/mL.
Linearity and Dilution 4.3.
4.3.1.
Linearity was assessed according to CLSI EP06-Ed2, study design B, using weighted linear regression analysis. At least seven concentrations using hemolysate samples were measured on the cobas e 801 analyzer to demonstrate that measurements across the claimed measuring range are linear. Linearity was confirmed to support the measuring range of 120 - 620 ng/mL.
4.3.2. Dilution
A dilution study was performed by using high concentration hemolysate samples that were diluted 1:2 using a 0.2% ascorbic acid solution. The data support instruction for use.
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Endogenous Interferences 4.4.
The effect of the following endogenous substances were evaluated for potential interference with Elecsys Folate III on the cobas e 801 analyzer. All predefined acceptance criteria were met, and the proposed labeling claims for each endogenous substance can be found below:
| Compound | Concentration tested |
|---|---|
| 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 |
4.5. Analytical Specificity/Cross-Reactivity
A cross-reactivity study was conducted with Elecsys Folate III on the cobas e 801 analyzer to evaluate the potential cross-reactivity of the assay with the following:
| Cross-reactant | Concentration testedng/mL | Cross-reactivity% |
|---|---|---|
| Amethopterin | 750 | 1.7 |
| Aminopterin | 750 | 2.0 |
| Folinic acid | 750 | 2.6 |
4.6. Exogenous Interferences
An exogenous interference study was conducted to evaluate 17 commonly and 1 specially used pharmaceutical (erythropoietin) compounds for potential interference with the Elecsys Folate III assay on the cobas e 801 analyzer. No interference was found.
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Sample Matrix Comparison 4.7.
The effect on quantitation of analyte in the presence of anticoagulants with Folate III was determined by comparing values obtained from native samples into various tubes containing anticoagulants. Whole blood samples were drawn into Na-Heparin and K3-EDTA tubes.
The results were within specification and support the use of hemolysate prepared from whole blood and treated with Na-heparin or K3-EDTA can be used.
Method Comparison to Predicate 4.8.
A method comparison was performed using the Elecsys Folate III updated assay and the Elecsys Folate RBC current assay. The results can be found below:
Number of samples measured: 119
| Passing/Bablok | Linear regression |
|---|---|
| y = 1.04x - 14.6 | y = 1.03x - 11.0 |
| τ = 0.913 | r = 0.991 |
The sample concentrations were between 132 and 618 ng/mL.
Reagent Stability 4.9.
Reagent On-board Stability 4.9.1.
On-board reagent stability for the Elecsys Folate III assay was tested on one cobas e 801 analyzer. Elecsys Folate III reagent kits can be stored on-board the analyzers for up to 16 weeks.
4.10. Calibration Stability
4.10.1. Lot Calibration Stability
Lot calibration frequency for Elecsys Folate III was tested on one cobas e 801 analyzer. Calibration of an Elecsys Folate III reagent lot is recommended every 12 weeks. During that time period, fresh reagent kits of the same lot can be used without calibration using the calibration curve of the day 0 reagent kit.
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4.10.2. On-board Calibration Stability
Reagent on-board calibration frequency for Elecsys Folate III was tested on one cobas e 801 analyzer. Elecsys Folate III epacks can be stored on board of the analyzers for up to 28 days without a new calibration.
5. EXTERNAL (CLINICAL) TESTING
Not Applicable
6. CLINICAL PERFORMANCE EVALUATION
Not Applicable
ADDITIONAL INFORMATION 7.
The Elecsys Folate III is intended to be used with the following calibrators and controls:
- CalSet Folate .
CalSet Folate is regulated under product code JIX and 21 CFR 862.1660, is exempt from Premarket notification, and therefore, is not included with this submission.
8. CONCLUSIONS
The information provided in this 510(k) Premarket Notification supports the determination that the updated Elecsys Folate III is substantially equivalent to the predicate device, Elecsys Folate RBC (K103716).
§ 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.