(31 days)
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.
Vitros Anti-HBc Controls contain two levels of controls in separate vials. Control 1: Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (anti-HIV 1+2) and hepatitis C virus (anti-HCV) using FDA approved methods (enzyme immunoassays). Control 2: Anti-HBc positive plasma diluted in normal human plasmas were obtained from donors who were tested individually and found to be negative HBsAg. and for antibodies to HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays). The anti-HBc positive plasma has also been tested and shown to be positive for anti-HBc antibody. Both controls contain antimicrobial agent. 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.
The provided document is a 510(k) summary for a medical device called "Vitros Immunodiagnostic Products Anti-HBc Controls". This device is a quality control material and not an AI/ML-driven diagnostic device. Therefore, the information requested in your prompt (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI performance validation) is not typically applicable or available in this type of regulatory submission for a control product.
The document focuses on demonstrating substantial equivalence to a predicate device for this control material, rather than proving diagnostic performance against acceptance criteria in the way an AI diagnostic would.
However, I can extract information relevant to acceptance criteria and performance as presented for this control device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the characteristics and intended use of the control device itself, and compares it to a predicate control device. It doesn't present "acceptance criteria" in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) but rather in terms of the characteristics of the control material and how its expected values are established.
| Characteristic | Acceptance Criteria (as described for new device) | Reported Device Performance (as described for new device) |
|---|---|---|
| Intended Use | For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). Performance not established with other anti-HBc assays. | The device meets this intended use, providing controls for the specified system and assay. |
| Matrix of Controls | Human serum with added antimicrobial agents. | Control 1: Normal human plasma. Control 2: Anti-HBc positive plasma diluted in normal human plasmas. Both contain antimicrobial agent. |
| Control Levels | Two levels of controls (Control 1 and Control 2) | Control 1 (Normal human plasma): Negative for HBsAg, anti-HIV 1+2, anti-HCV. Control 2 (Anti-HBc positive plasma): Positive for anti-HBc antibody, negative for HBsAg, anti-HIV 1+2, anti-HCV. |
| Expected Values | Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations in a number of different laboratories using different reagent lots. Values are lot specific. | Values are assigned from a minimum of 10 assays. The standard deviation is stated to be that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches. |
Study Proving Device Meets Acceptance Criteria:
The document states: "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 indicates a multi-laboratory study was performed to establish the expected values and variability of the controls.
2. Sample size used for the test set and the data provenance:
- Test set sample size: For establishing control values, it is stated that values are assigned from a minimum of 10 assays. This implies at least 10 measurements were taken for each control level to determine its mean and standard deviation.
- Data provenance: The document does not specify the country of origin of the data. It mentions "human plasma obtained from donors" and "different laboratories." The study appears to be prospective in nature for the establishment of control values, as these controls are created and then characterized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for a control material is its chemical or biological composition (e.g., "negative for HBsAg," "positive for anti-HBc antibody") and its performance characteristics (mean and standard deviation). These are established through laboratory testing, not by expert consensus or interpretation in the way an AI diagnostic would require.
4. Adjudication method for the test set:
Not applicable for a control material characterization.
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 device is a quality control material, not an AI diagnostic that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical control material, not an algorithm.
7. The type of ground truth used:
The ground truth for the control materials themselves is their inherent biological status and quantitative assays.
- Control 1: "Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (anti-HIV 1+2) and hepatitis C virus (anti-HCV) using FDA approved methods (enzyme immunoassays)."
- Control 2: "Anti-HBc positive plasma... tested and shown to be positive for anti-HBc antibody" and "negative for HBsAg, and for antibodies to HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays)."
The "ground truth" for the assigned values (mean and standard deviation) is the statistical analysis of experimental results from repeated measurements.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
{0}------------------------------------------------
OCT 3 1 2003
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: K63 3127
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-4469
Contact Person: Sarah Parsons
Date 510(k) prepared: September 29, 2003
Device Name 2.
Trade or Proprietary Name: Vitros Immunodiagnostic Products Anti-HBc Controls Common Name: anti-HBc controls Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).
3. Predicate Device
The Vitros Immunodiagnostic Products Anti-HBc Controls are substantially equivalent to Blackhawk BioSystems, Inc. VIROTROL® I (BK930016).
4. Device Description
Vitros Anti-HBc Controls contain two levels of controls in separate vials.
Control 1
Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (anti-HIV 1+2) and hepatitis C virus (anti-HCV) using FDA approved methods (enzyme immunoassays).
Control 2
Anti-HBc positive plasma diluted in normal human plasmas were obtained from donors who were tested individually and found to be negative HBsAg. and for antibodies to
{1}------------------------------------------------
HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays). The anti-HBc positive plasma has also been tested and shown to be positive for anti-HBc antibody.
Both controls contain antimicrobial agent.
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.
5. Device Intended Use
The Vitros Anti-HBc Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.
6. Comparison to Predicate Device
The Vitros Immunodiagnostic Products Anti-HBc Controls are substantially equivalent to Blackhawk BioSystems, Inc. VIROTROL® I (BK930016).
Table 1 lists the similarities and differences of the device characteristics between the Vitros Anti-HBc Controls and the predicate device.
{2}------------------------------------------------
| Table 1 Characteristics of the Controls | |||
|---|---|---|---|
| -- | ----------------------------------------- | -- | -- |
| Characteristics | New Device | Predicate Device | |
|---|---|---|---|
| Intended use | For use in monitoring theperformance of the Vitros ECiImmunodiagnostic System whenused for the in vitro qualitativedetection of total antibody (IgGand IgM) to hepatitis B coreantigen (total anti-HBc) in humanserum and plasma (EDTA andcitrate). The performance of theVitros ImmunodiagnosticProducts Anti-HBc Controls hasnot been established with anyother anti-HBc assays. | VIROTROL I is intended for use with invitro assay procedures for determinationof antibodies to HumanImmunodeficiency Virus Type 1 (HIV-1),antibodies to Human T-LymphotropicVirus Type I (HTLV-I), antibodies toHepatitis C Virus (HCV), Hepatitis BSurface Antigen (HBsAg), antibodies toHepatitis B Core Antigen (HBc) andantibodies to cytomegalovirus (CMV).VIROTROL reagents are intended toprovide a means of estimating precisionand have the potential for detectingsystematic deviations from specificlaboratory testing procedures. | |
| Matrix of controls | Human serum with addedantimicrobial agents | Human serum or plasma with addedstabilizers and preservative. | |
| Control levels | Positive and negative | ||
| Expected values | Each control has a quoted meanvalue derived from a minimum of10 assays and a standarddeviation anticipated for singledeterminations of each control ina number of different laboratoriesusing different reagent lots.Values are lot specific. | VIROTROL 1® controls do not haveassigned values, but are formulated toproduce positive reactivity in the listedmanufacturer's assays. Specific levels ofreactivity will vary among differentmanufacturers' assays, differentprocedures, different reagent lot numbers,and different laboratories. Each laboratoryshould establish its own range ofacceptable values for each analyte. |
7. Conclusions
The information presented in the pre-market notification demonstrates that the Vitros Anti-HBc Controls are substantially equivalent to the predicate device Blackhawk BioSystems, Inc. VIROTROL 1® Multi-Marker Positive Control which was cleared by FDA (BK930016).
The information presented in the premarket notification provide a reasonable assurance that the Vitros Anti-HBc Controls are safe and effective for the stated intended use.
{3}------------------------------------------------
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 caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 3 1 2003
Ms. Sarah Parsons Associate, Regulatory Affairs Ortho Clinical Diagnostics 100 Indigo Creek Park Rochester, NY 14626-5101
Re: K033127
Trade/Device Name: Vitros Immunodiagnostic Products Anti-HBc Controls Regulation Number: 21 CFR 866.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 29, 2003 Received: September 30, 2003
Dear Ms. Parsons:
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 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).
{4}------------------------------------------------
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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):
Device Name:
Vitros Immunodiagnostic Products Anti-HBc Controls
Indications for Use:
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.
Page 1 of 1
(PLEASE DO NOT WRITE BENGLE CONTINUE ON ANOTHER PAGE IF NEEDED)
,在""
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
Division Sign-Off
| Prescription Use | Office of In Vitro Diagnostic Device | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | Evaluation and Safety | ||
| (Optional Format 1-2-96) |
510(k) K033127Onho-Clinical Diagnostics
2
§ 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.