(33 days)
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No
The device description details controls for an immunoassay system, which are chemical reagents used for quality control, and there is no mention of AI or ML in the provided text.
No
This device is for in vitro diagnostic use, specifically for monitoring the performance of an immunodiagnostic system, not for treating a disease or condition in a patient.
No
The device description clarifies that these are "controls" used to monitor the performance of an immunodiagnostic system, not to directly diagnose a patient's condition.
No
The device description clearly states the controls are comprised of physical substances (plasma, antimicrobial agent) and are freeze-dried, indicating a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Intended Use: The device is intended for "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". This describes a test performed in vitro (outside the body) on a human sample (serum) to provide information about a medical condition (presence of anti-HBs).
- Device Description: The description details the composition of the controls, which are used to verify the accuracy and reliability of an in vitro diagnostic test.
Therefore, based on the provided text, the device is an In Vitro Diagnostic.
No
Explanation: There is no mention or indication within the provided text that this device is authorized under a Predetermined Change Control Plan (PCCP). PCCPs are a specific FDA authorization pathway for certain AI/ML-enabled devices, allowing for pre-agreed modifications without requiring a new 510(k) submission for each change. This clearance letter describes a traditional IVD control product.
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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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.
2
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 | ||
|---|---|---|
| Device | ||
| Characteristic | VITROS Immunodiagnostic | |
| Products Anti-HBs Controls | ||
| (New device) | VITROS Immunodiagnostic | |
| Products Anti-HBs Controls | ||
| (Predicate device) | ||
| Intended use | 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 use in monitoring the | |
| performance of the VITROS | ||
| Immunodiagnostic System | ||
| when used for the qualitative in | ||
| vitro determination of total | ||
| antibody to Hepatitis B surface | ||
| antigen (anti-HBs) in human | ||
| serum when using the VITROS | ||
| Immunodiagnostic Products | ||
| Anti-HBs Reagent Pack on the | ||
| VITROS ECi | ||
| Immunodiagnostic System. | ||
| The performance of the | ||
| VITROS Immunodiagnostic | ||
| Products Anti-HBs Controls | ||
| has not been established with | ||
| any other anti-HBs assays. | ||
| Matrix of | ||
| controls | Human serum with added | |
| constituents of human origin | ||
| and antimicrobial agents | Human serum with added | |
| constituents of human origin | ||
| and antimicrobial agents | ||
| Control level | 2 Positive and 1 negative | 1 Positive and 1 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. | 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 |
| 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) |