(21 days)
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
The Elecsys Folate II Assay employs a competitive test principle. In the first step, bound folate in the sample is released from endogenous folate binding proteins through incubation with pretreatment reagents. In the second step, ruthenium labeled folate binding protein complexes with the sample. In the third step, after the addition of streptavidin-coated microparticles and folate labeled with biotin, the unbound sites of the ruthenium labeled folate binding protein become occupied, with formation of a ruthenium labeled folate binding protein-folate biotin complex. The complex becomes bound to the solid phase. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for complex medical devices like AI algorithms or imaging analysis tools. This document is a 510(k) summary for an immunoassay, which is a laboratory test.
The document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining stringent acceptance criteria and performance against them. Information provided mainly compares the new device to a previous version and confirms its intended use and technical specifications.
Therefore, many of the requested points cannot be directly answered from the provided text. However, I will extract relevant information where available and note when information is not present.
Acceptance Criteria and Device Performance for Elecsys® Folate II Immunoassay
The provided document is a 510(k) summary for an in vitro diagnostic immunoassay. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to detail the specific performance metrics and acceptance criteria in the same way one would for a novel AI device or imaging system. Therefore, an explicit table of acceptance criteria with reported device performance is not present in this format.
The "performance" in this context is demonstrated through similarities to the predicate device and the continuation of the intended use. The key aspects highlighted are the measuring range and expected values, which are consistent with the predicate device.
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Table of Acceptance Criteria and Reported Device Performance:
Note: The document does not provide a formal table of acceptance criteria with corresponding performance data for the specific changes in the modified device. Instead, it details that the modified device has the "Same" performance characteristics as the predicate device (K031756) for several key attributes. The main change noted in performance is the stability of the opened reagent on the analyzer.
Characteristic Predicate Device (K031756) Performance Modified Device Performance (Elecsys® Folate II) Implicit "Acceptance Criteria" (by equivalence) Intended Use Quantitative determination of folate in human serum, for Elecsys 2010 and MODULAR ANALYTICS E170. Same Must meet the same intended use. Indications for Use Diagnosis and treatment of anemias of gastrointestinal malabsorption. Diagnosis and treatment of anemias. Must indicate use in diagnosis/treatment of anemias. (Slight broadening in modified device) Test Principle Competitive chemiluminescence Same Must be competitive chemiluminescence. Sample Type Serum Same Must use serum. Expected Values 3.1-17.5 ng/ml Same Must fall within 3.1-17.5 ng/ml. Measuring Range 0.600-20.00 ng/ml Same Must be 0.600-20.00 ng/ml. Traceability Standardized against Elecsys Folate (itself against a commercial radiobinding assay). Standardized against Elecsys Folate. Must maintain traceability to Elecsys Folate. Stability (Opened) At 2-8°C for 12 weeks; On E170/2010 for 6 weeks. At 2-8°C for 12 weeks; On E170/2010 for 1 week. Must demonstrate specified stability (note change). (The "Acceptance Criteria" column is inferred from the declaration of "Same" or the stated values for the predicate device, as the submission relies on substantial equivalence.)
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Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" or its sample size. The substantial equivalence is largely based on the device's formulation, method, and a slight modification in stability on one analyzer, implying that comprehensive re-testing on a new clinical sample set was not the primary focus of this specific 510(k) submission. Data provenance is not mentioned. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is an immunoassay, and "ground truth" for clinical performance is typically established by comparison to reference methods or clinical outcomes, not expert consensus on individual "cases." The performance is inherent to the chemical reactions and detection system. -
Adjudication method for the test set:
Not applicable. No "test set" requiring adjudication by experts is described. -
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 immunoassay, not an imaging or AI-assisted diagnostic device that involves human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an immunoassay, which is a standalone measurement device without a human-in-the-loop component in its analytical operation. -
The type of ground truth used:
For an immunoassay, ground truth is established through analytical validation comparing results to known standards, reference methods, and correlation with clinical conditions. The document mentions traceability to "Elecsys Folate which was itself standardized against a commercially available radiobinding folate assay" for both the predicate and modified device. This implies the "ground truth" for standardization is established by comparison to a recognized, validated method for folate measurement. -
The sample size for the training set:
Not applicable. This is an immunoassay, not a machine learning or AI device that uses "training sets" in the conventional sense. -
How the ground truth for the training set was established:
Not applicable. As above, this is an immunoassay. The device's performance is based on its chemical and physical principles, not on learning from a training set. Standardization against a reference method serves a similar function to establishing accuracy, but it's not a "training set" in the AI context.
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DEC 2 3 2004
510(k) Summary - Elecsys® Folate II
| 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 RdIndianapolis IN 46250(317) 521-3544 |
| Contact person: Kay A. Taylor | |
| Date prepared: December 1, 2004 | |
| Device Name | Proprietary name: Roche Elecsys® Folate II Immunoassay |
| Common name: Folate Assay | |
| Classification name: Acid, Folic, Radioimmunoassay | |
| Devicedescription | The Elecsys Folate II Assay employs a competitive test principle. In the firststep, bound folate in the sample is released from endogenous folate bindingproteins through incubation with pretreatment reagents. In the second step,ruthenium labeled folate binding protein complexes with the sample. In thethird step, after the addition of streptavidin-coated microparticles and folatelabeled with biotin, the unbound sites of the ruthenium labeled folate bindingprotein become occupied, with formation of a ruthenium labeled folatebinding protein-folate biotin complex. The complex becomes bound to thesolid phase. The reaction mixture is aspirated into the measuring cell wherethe microparticles are magnetically captured onto the surface of the electrode,unbound substances are removed. Voltage is applied to the electrodeinducing chemiluminescent emission which is measured by a photomultiplier.Results are determined using a calibration curve that is generated specificallyon each instrument by a 2 point calibration and a master curve provided withthe reagent bar code. |
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510(k) Summary - Elecsys® Folate II, continued
| Intended use | Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
|---|---|
| Predicate Device | We claim substantial equivalence to the Elecsys Folate II Immunoassay currently marketed on the MODULAR ANALYTICS E170. (K031756). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate II (K031756) and the Elecsys Folate II (modified device). |
| Topic | Elecsys® Folate II (K031756) | Elecsys® Folate II (Modified Device) |
|---|---|---|
| Intended Use | Binding assay for the in vitroquantitative determination of folate inhuman serum.The binding assay is intended for useon the Roche Elecsys 2010 andMODULAR ANALYTICS E170(Elecsys module) immunoassayanalyzers. | Binding assay for the in vitroquantitative determination of folate inhuman serum.The binding assay is intended for useon the Roche Elecsys 2010 andMODULAR ANALYTICS E170(Elecsys module) immunoassayanalyzers. |
| Indications forUse | Measurements obtained by thisdevices are used in the diagnosis andtreatment of anemias of thegastrointestinal malabsorption. | Measurements obtained by thisdevices are used in the diagnosis andtreatment of anemias |
| Test Principle | Competitive chemiluminescence | Same |
| Sample Type | Serum | Same |
| ExpectedValues | 3.1-17.5 ng/ml | Same |
| Measuringrange | 0.600-20.00 ng/ml | Same |
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510(k) Summary - Elecsys® Folate II, continued
| Topic | Elecsys® Folate II(K031756) | Elecsys® Folate II(Modified Device) |
|---|---|---|
| Traceability | Standardized against Elecsys Folatewhich was itself standardized against acommercially available radiobindingfolate assay | Standardized against Elecsys Folate |
| Stability | Store at 2-8°C unopened up to theexpiration date. | Same |
| Opened: | Opened: | |
| At 2-8°C for 12 weeks | Same | |
| On E170 / 2010 for 6 weeks | On E170 / 2010 for 1 week |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines emanating from its head, representing the department's focus on health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2004
Ms. Kay A. Taylor MT (ASCP), RAC Regulatory Affairs Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Rd. PO Box 50457 Indianapolis, IN 46250-0457
Re: K043318
Trade/Device Name: Roche Elecsys Folate II Immunoassay Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: December 1, 2004 Received: December 2, 2004
Dear Ms. Taylor:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my Journe FDA finding of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain other general manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Caul C. Benson for
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043318
Device Name: Roche Elecsys Folate II Immunoassay
Indications For Use:
Binding assay for the in vitro quantitative determination of folate in human Measurements obtained by this devices are used in the diagnosis and serum. treatment of anemias.
The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use - - -(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benam
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safely
510(k) k0413318
§ 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.