(33 days)
The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.
For in vitro diagnostic use.
The VITROS Immunodiagnostic Products Anti-HBs Controls are comprised of three levels of controls in separate vials:
Control 1 (Negative)
Anti-HBs negative plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA).
Control 2 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).
Control 3 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 380 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).
All controls contain antimicrobial agent and are freeze-dried.
The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.
This document describes the VITROS Immunodiagnostic Products Anti-HBs Controls, which are quality control materials used to monitor the performance of the VITROS Immunodiagnostic System for quantitative determination of anti-HBs in human serum.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify explicit acceptance criteria (e.g., precision limits, accuracy targets) for the device performance study. Instead, it describes how the control values are established and states that the new device is substantially equivalent to a predicate device based on their characteristics.
The "reported device performance" in this context refers to how the control values are assigned and their intended use, rather than specific performance metrics like sensitivity or specificity for a diagnostic test.
| Characteristic | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Control Levels | Not explicitly stated as acceptance criteria | Three levels: Control 1 (Negative), Control 2 (Positive), Control 3 (Positive) |
| Matrix | Not explicitly stated as acceptance criteria | Human serum with added constituents of human origin and antimicrobial agents |
| Expected Values | Not explicitly stated as acceptance criteria | Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations in different laboratories using different reagent lots. Values are lot specific. |
| Safety Testing | Not explicitly stated as acceptance criteria | All plasma donors for controls were tested and found negative for HIV 1+2 and HCV using FDA approved methods (EIA). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of evaluating the device's diagnostic accuracy. The study described is for establishing the values of the control materials themselves.
- Sample Size for Controls Value Assignment: "The controls are assigned values from a minimum of 10 assays." This refers to the number of assays performed to determine the mean and standard deviation for each control lot.
- Data Provenance: The plasma for the controls is obtained from human donors. The document does not specify the country of origin. It indicates that the plasma sources were tested using FDA-approved methods. The study described is retrospective in the sense that the plasma is collected and then prepared into controls, followed by value assignment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of device and study described. This is a quality control material, not a diagnostic test that requires expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable to the type of device and study described, as there is no diagnostic test performance being adjudicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted and is not relevant for this type of quality control device.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study, as typically understood for diagnostic algorithms, was not conducted and is not relevant for this type of quality control device. The "performance" described is the process of assigning values to the control materials, which are then used to monitor the performance of an immunodiagnostic system.
7. Type of Ground Truth Used
The "ground truth" for the control materials is established through:
- Reference Method/Assay: For the positive controls (Control 2 and 3), anti-HBs negative plasma was "spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL" and "380 mIU/mL" respectively. This indicates a target concentration.
- Assay-derived Values: The final assigned values (mean and standard deviation) for each control are derived from "a minimum of 10 assays" performed on the VITROS Immunodiagnostic System. So, the ground truth for the value itself is derived from the performance of the system it's designed to control, rather than an independent external gold standard in the typical sense of a diagnostic test.
- Donor Screening: For safety, the plasma used was screened for HIV 1+2 and HCV using FDA-approved EIA methods.
8. Sample Size for the Training Set
The document describes the process for establishing the values of the controls, not a machine learning algorithm with a training set. As such, there is no "training set" in the context of AI/ML. The "minimum of 10 assays" mentioned in #2 is for value assignment, not model training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable. The ground truth for the control values themselves, as described in #7, is based on a combination of spiking to achieve nominal concentrations and empirical determination through multiple assays on the target instrument.
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GENERAL INFORMATION 2.0
510(k) Summary 2.1
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: K048303
Submitter Name, Address, Contact 2.1.1
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3154
Sarah Glover Contact Person:
Preparation Date 2.1.2
August 24, 2004 Date 510(k) Summary Prepared:
Device Name 2.1.3
Trade or Proprietary Name: VITROS Immunodiagnostic Products Anti-HBs Controls
Common Name:
Anti-HBs Controls
Classification Name:
21CFR 862.1660 Quality Control Material (Assayed and Unassayed).
Predicate Device 2.1.4
The VITROS Immunodiagnostic Products Anti-HBs Controls are substantially equivalent to the current VITROS Immunodiagnostic Products Anti-HBs Controls (K003112).
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Device Description 2.1.5
The VITROS Immunodiagnostic Products Anti-HBs Controls are comprised of three levels of controls in separate vials:
Control 1 (Negative)
Anti-HBs negative plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA).
Control 2 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).
Control 3 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 380 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).
All controls contain antimicrobial agent and are freeze-dried.
The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.
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Device Intended Use 2.1.6
The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.
Comparison to Predicate Device 2.1.7
The VITROS Immunodiagnostic Products Anti-HBs Controls are substantially equivalent to the current VITROS Immunodiagnostic Products Anti-HBs Controls (K003112).
Table 1 lists the characteristics of the VITROS Immunodiagnostic Products Anti-HBs Controls (new device) and the current VITROS Immunodiagnostic Products Anti-HBs Controls (predicate device).
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| Table 1: Comparison of New Device and Predicate Device | ||
|---|---|---|
| DeviceCharacteristic | VITROS ImmunodiagnosticProducts Anti-HBs Controls(New device) | VITROS ImmunodiagnosticProducts Anti-HBs Controls(Predicate device) |
| Intended use | For use in monitoring theperformance of the VITROSImmunodiagnostic Systemwhen used for the quantitativein vitro determination of totalantibody to Hepatitis B surfaceantigen (anti-HBs) in humanserum when using theVITROS ImmunodiagnosticProducts Anti-HBsQuantitative Reagent Pack onthe VITROSImmunodiagnostic System.The performance of theVITROS ImmunodiagnosticProducts Anti-HBs Controlshas not been established withany other anti-HBs assays. | For use in monitoring theperformance of the VITROSImmunodiagnostic Systemwhen used for the qualitative invitro determination of totalantibody to Hepatitis B surfaceantigen (anti-HBs) in humanserum when using the VITROSImmunodiagnostic ProductsAnti-HBs Reagent Pack on theVITROS ECiImmunodiagnostic System.The performance of theVITROS ImmunodiagnosticProducts Anti-HBs Controlshas not been established withany other anti-HBs assays. |
| Matrix ofcontrols | Human serum with addedconstituents of human originand antimicrobial agents | Human serum with addedconstituents of human originand antimicrobial agents |
| Control level | 2 Positive and 1 negative | 1 Positive and 1 negative |
| Expected values | Each control has a quotedmean value derived from aminimum of 10 assays and astandard deviation anticipatedfor single determinations ofeach control in a number ofdifferent laboratories usingdifferent reagent lots. Valuesare lot specific. | Each control has a quotedmean value derived from aminimum of 10 assays and astandard deviation anticipatedfor single determinations ofeach control in a number ofdifferent laboratories usingdifferent reagent lots. Valuesare lot specific |
| Table 1. Comparison of New Device and Predicate Device | |||
|---|---|---|---|
| -------------------------------------------------------- | -- | -- | -- |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three parallel lines that curve and converge, resembling a stylized representation of a staff with snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 7 2004
Ms. Sarah Glover Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626
Re: K042303
Trade/Device Name: VITROS Immunodiagnostic Products Anti-HBs Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 24, 2004 Received: August 25, 2004
Dear Ms. Glover:
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 r ou may 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, s you stons on the promotion and advertising of your device, please contact the Office of of questions on the promise Evaluation and Safety at (301) 594-3084. 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 Tod may 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saqartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.2
Page 1 of 1
510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products Anti-HBs Controls
Indications for Use:
The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.
For in vitro diagnostic use.
ﺮ, ﺍﻷ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | K042303 |
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional 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.