(84 days)
The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions.
The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance criteria beyond general statements about evaluation of assay precision, demonstration of linearity, and correlation with a predicate device. The document primarily focuses on regulatory approval and equivalence to a predicate device.
However, based on the information provided, we can infer some details related to the study conducted.
Here's an attempt to structure the information based on your request, with significant caveats that much of the detailed information you asked for is not present in the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from studies performed) |
|---|---|
| Assay Precision acceptable per NCCLS recommendations | Evaluation of assay precision according to NCCLS recommendations (result not detailed) |
| Demonstration of linearity | Demonstration of linearity (result not detailed) |
| Correlation with predicate device | Correlation with the predicate device (result not detailed) |
| Suitability for various sample types | Sample type studies (result not detailed) |
| Performance of the Elecsys® Red Blood Cell Folate Lysing Reagent in combination with the Elecsys® Folate Assay for quantitation of folate in human red blood cells. | The device is intended for this use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer. Studies were performed to support this. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The context suggests a laboratory assay, so "experts" in the clinical interpretation sense might not be directly applicable for establishing ground truth for the raw assay results themselves, but rather for clinical validation or interpretation of results.
4. Adjudication method for the test set
Not specified.
5. 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 in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging device requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. This is an IVD assay. Its performance is evaluated as a standalone system (reagent + analyzer) that produces a quantitative result without a "human-in-the-loop" step in generating the primary measurement. The "study" here refers to the analytical performance of the assay itself.
7. The type of ground truth used
For an IVD assay like this, the "ground truth" for assay performance evaluation is typically established through:
- Reference Methods: Using established, highly accurate analytical methods to determine true folate concentrations in samples.
- Known Concentration Samples: Using samples with accurately known concentrations of the analyte (e.g., spiked samples, certified reference materials).
- Clinical Samples with Clinical Diagnosis: For correlation studies, comparing assay results to a clinical diagnosis (though the document only mentions correlation with the predicate device, not directly with patient outcomes).
- Predicate Device Comparison: The document explicitly mentions "correlation with the predicate device," implying the predicate device's results serve as a comparative "ground truth" or standard.
8. The sample size for the training set
Not applicable in the context of traditional machine learning "training sets" as this is a chemical assay, not an AI algorithm. The assay itself doesn't have a "training set" in that sense. However, the development and optimization of the assay would involve various experiments and sample analyses, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '981931', and ends with a vertical line. The characters are written in a dark ink, and the background is white.
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics/Boehringer Mannheim Corporation4300 Hacienda DrivePleasanton, CA 94566-0900(925) 730-8215Contact Person: Patricia M. KlimleyDate Prepared: June 1, 1998 |
| 2) Device name | Proprietary name: Elecsys® Red Blood Cell Folate Lysing ReagentCommon name: Elecsys® Red Blood Cell Folate Lysing Reagent is to be usedin combination with the Elecsys® Folate Assay for the quantitation of folate inhuman red blood cells.Classification name: Folate Test System. |
| 3) Predicatedevice | We claim substantial equivalence to the Bio-Rad Quantaphase II® FOLATERadiobinding assay (K935286). |
| 4) DeviceDescription | The Elecsys® test principle is based on the competitive principle. Totalduration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions. |
| 5) Intended use | The Elecsys Red Blood Cell Folate Lysing Reagent is to be used incombination with the Elecsys Folate Assay for the quantitation of folate inhuman red blood cells.The electrochemiluminescence assay "ECLIA" is intended for use on theBoehringer Mannheim Elecsys 2010 immunoassay analyzer. |
| 6) Comparisonto predicatedevice | The Roche Diagnostics/Boehringer Mannheim Elecsys Red Blood Cell Folateis substantially equivalent to other products in commercial distributionintended for similar use. Most notably it is substantially equivalent to thecurrently marketed Bio-Rad Quantaphase II® Folate Radiobinding assay . |
| Elecsys studies performed include:• evaluation of assay precision according to NCCLS recommendations• demonstration of linearity• correlation with the predicate device• sample type studies |
Continued on next page
{1}------------------------------------------------
510(k) Summary, Continued
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 25 1998
Patricia M. Klimley Regulatory Affairs Manager Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re: K981931 Elecsys® Red Blood Cell Folate Lysing Reagent Requlatory Class: II Product Code: CGN Dated: June 1, 1998 Received: June 2, 1998
Dear Ms. Klimley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{3}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): Device Name: Elecsys® Red Blood Cell Folate Lysing Reagent Indications for Use:
The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number ___ ﺎ
§ 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.