(31 days)
BK930016
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No
The document describes controls for an immunodiagnostic system, focusing on the composition and intended use of the control materials. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is used for monitoring the performance of an immunodiagnostic system for in vitro qualitative detection, not for treating any medical condition.
No
This device is described as a control for monitoring the performance of an immunodiagnostic system, not as a diagnostic device itself.
No
The device description clearly indicates the device is a physical product containing human plasma and antimicrobial agents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "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..." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The device description details the composition of the controls, which are derived from human plasma and used to assess the performance of an immunodiagnostic system. This aligns with the nature of IVD controls.
- Predicate Device: The mention of a predicate device (BK930016; Blackhawk BioSystems, Inc. VIROTROL® I) which is also a control for an immunodiagnostic system further supports its classification as an IVD.
The device is a control material used to verify the performance of an IVD assay (the Vitros ECi Immunodiagnostic System) that detects antibodies in human samples. This function falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JJX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
BK930016
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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.
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| Table 1 Characteristics of the Controls | |||
|---|---|---|---|
| -- | ----------------------------------------- | -- | -- |
| Characteristics | New Device | Predicate Device | |
|---|---|---|---|
| Intended 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. | VIROTROL I is intended for use with in | ||
| vitro assay procedures for determination | |||
| of antibodies to Human | |||
| Immunodeficiency Virus Type 1 (HIV-1), | |||
| antibodies to Human T-Lymphotropic | |||
| Virus Type I (HTLV-I), antibodies to | |||
| Hepatitis C Virus (HCV), Hepatitis B | |||
| Surface Antigen (HBsAg), antibodies to | |||
| Hepatitis B Core Antigen (HBc) and | |||
| antibodies to cytomegalovirus (CMV). | |||
| VIROTROL reagents are intended to | |||
| provide a means of estimating precision | |||
| and have the potential for detecting | |||
| systematic deviations from specific | |||
| laboratory testing procedures. | |||
| Matrix of controls | Human serum with added | ||
| antimicrobial agents | Human serum or plasma with added | ||
| stabilizers and preservative. | |||
| Control levels | Positive and negative | ||
| Expected values | Each control has a quoted mean | ||
| value derived from a minimum of | |||
| 10 assays and a standard | |||
| deviation anticipated for single | |||
| determinations of each control in | |||
| a number of different laboratories | |||
| using different reagent lots. | |||
| Values are lot specific. | VIROTROL 1® controls do not have | ||
| assigned values, but are formulated to | |||
| produce positive reactivity in the listed | |||
| manufacturer's assays. Specific levels of | |||
| reactivity will vary among different | |||
| manufacturers' assays, different | |||
| procedures, different reagent lot numbers, | |||
| and different laboratories. Each laboratory | |||
| should establish its own range of | |||
| acceptable 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.
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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).
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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
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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.
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(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
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