(28 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay). 2. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS ECi System in each assay.
The provided text describes a 510(k) summary for a medical device called "VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers." This document establishes the device's substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing of a novel device.
The document primarily focuses on:
- Device Description: What the device is and how it functions generally within the VITROS Immunodiagnostic System.
- Intended Use: For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System for Vitamin B12 measurement.
- Comparison to Predicate Device: Table 1 lists the similarities and differences between the new device and the predicate device, specifically regarding intended use, matrix composition, and target concentrations of the range verifier levels.
- Conclusion of Substantial Equivalence: The document asserts that the new device is substantially equivalent to the predicate device based on physical properties and intended uses.
Therefore, I cannot provide the requested information. The document explicitly focuses on demonstrating substantial equivalence, not on presenting performance data from a primary study of a new device against acceptance criteria.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, agreement rates) or detailed performance results are presented. The "Range Verifier levels" in Table 1 are target concentrations for the verification materials, not performance metrics.
- Sample size used for the test set and the data provenance: Not applicable, as no performance study data is included.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: This device is a range verifier for an immunoassay system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to AI/algorithm performance, which is not applicable to this device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study data is included.
- The sample size for the training set: Not applicable, as this device is not based on a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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Chapter 1 - Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: _KO13900
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-4041
Contact Person: Marlene A. Shulman
Date 510(k) prepared: November 21, 2001
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers
Common Name: Range Verifiers
Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Vitamin B12.
3. Predicate Device
The VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers (K990026).
4. Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Range Verifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to verify the performance of the VITROS assay).
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510(k) Summary, Continued.
-
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS ECi System in each assay. The VITROS Common rougents asocures Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).
The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS Vitamin B12 Range Verifiers (predicate device), which was approved by FDA (K990026) for IVD use.
Table 1 lists the similarities and differences of the device characteristics between the VITROS Vitamin B12 Range Verifiers with the predicate device, previously-cleared VITROS Vitamin B12 Range Verifiers.
Continued on next page
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510(k) Summary, Continued
Table 1 List of the assay characteristics
| Characteristics | New Device | Predicate Device |
|---|---|---|
| Intended use | For use in verifying the calibrationrange of the VITROSImmunodiagnostic System whenused for the measurement ofVitamin B12. | For use in verifying the calibrationrange of the VITROSImmunodiagnostic System whenused for the measurement ofVitamin B12. |
| Matrix of RangeVerifiers | Buffered matrix containing liquidhuman serum albumin | Buffered matrix containing liquidhuman serum albumin |
| Range Verifier levels | Low:Target Concentration: <90 pg/mL | Low:Target Concentration: <50 pg/mL |
| High Level:Target Concentration: 925 pg/mL | High Level:Target Concentration: 1900 pg/mL |
7. Conclusions
The data presented in the pre-market notification demonstrate that the VITROS Vitamin B12 Range Verifiers are substantially equivalent to the predicate device, for which there is FDA clearance.
Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents.
The data presented in the premarket notification provide a reasonable assurance that the VITROS Vitamin B12 Range Verifiers are safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K013900
KU13900
Trade/Device Name: VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: November 21, 2001 Received: November 23, 2001
Dear Ms. Shulman:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your bector 3 re(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) the enactment date of the Medical Device American Frances (Fried Days conninered provinces that they 20, 1978, are cannot with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). allo Cosmetic Act (110) that to nov roquilible to the general controls provisions of the Act. The I ou may, dieroloro, manov are a ct include requirements for annual registration, listing of general connois provisions of tactice, 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 If your device is olassimod (600 a00 roy als. Existing major regulations affecting your device can may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advisod that I DTC issualite over device complies with other requirements of the Act that I Dri has made a dolly and regulations administered by other Federal agencies. You must or any I oderal statues and regirements, including, but not limited to: registration and listing (21 eomply with an the 11th 011 0 0 0 1 0 0 manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the qualion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 nredicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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
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Statement of Intended Use
| 510(k) Number (if known): | K013900 |
|---|---|
| Device Name: | VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers |
| Indications for Use: | For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of Vitamin B12. |
Page 1 of 1(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K013900
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ ← (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Qptional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.