(10 days)
No
The summary describes a standard immunoassay system and controls for detecting HBsAg. There is no mention of AI, ML, or any computational methods that would suggest their use. The performance studies focus on validating the controls across different sample matrices, not on evaluating an AI/ML algorithm.
No.
The device is for in vitro diagnostic use to monitor the performance of an immunodiagnostic system for the qualitative detection of Hepatitis B Surface Antigen (HBsAg). It does not directly treat or diagnose a condition in a patient.
No
The device is described as "For use in monitoring the performance of the Vitros ECi Immunodiagnostic System" and "The Vitros Immunodiagnostic Products HBsAg Controls". It is a control system used to assess the performance of a diagnostic device, not a diagnostic device itself.
No
The device description explicitly mentions "The Vitros Immunodiagnostic System- instrumentation" and "Common reagents," indicating the presence of hardware and physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Purpose: The device is intended for "monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma..." This describes a product used in a laboratory setting to assess the performance of another diagnostic test, which is a common function of IVD devices (specifically controls).
- Sample Type: The device is used with "human serum and plasma," which are biological samples typically analyzed in vitro for diagnostic purposes.
- System Context: The "Device Description" explains that it's part of the "Vitros Immunodiagnostic System," which is designed for "in the qualitative detection of HBsAg in human plasma and serum." This further reinforces its role within a diagnostic workflow.
Therefore, based on the provided text, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, heparin or citrate). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
MJX
Device Description
The Vitros Immunodiagnostic System uses luminescence as the signal in the qualitative detection of HBsAg in human plasma and serum. Coated microwells are used as the solid phase separation system.
The system is compromised of three main elements:
- The Vitros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic Products HBsAg Reagent Pack and Vitros Immunodiagnostic Products Calibrator, which are combined by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator have been approved for sale (PMA P000044).
- The Vitros Immunodiagnostic System- instrumentation, which provides automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared be market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the Vitros System in each assay. The Vitros Immunodiagnostic Products Signal Reagent and the Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).
The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The new device is the same as the predicate device with the addition of data that supports a modification in the Intended Use. Additional data demonstrate the use of the controls to assess the performance of the Vitros Immunodiagnostic Products HBsAg assay when determining the qualitative detection of HBsAg in human plasma (EDTA, citrate and heparin) in addition to serum. Included in this 510(k) submission is the technical report that describes the assessment of multiple samples collected as either whole serum or in the presence of EDTA citrate or heparin. Each sample was tested either unspiked (negative) or spiked with known positive HBsAg plasma close to the weak positive detection level of the assay (positive). The results showed that all samples (serum, EDTA, citrate or heparin) behave similarly in the assay supporting that the controls can monitor the assay performance regardless of the tested sample matrix (serum or plasma).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
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.
0
General Information 2.0
JAN 1 7 2003
Confidential and Proprietary
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: ______________
Submitter Name, Address, Contact 2.1.1
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3154
Contact Person: Sarah Parsons
2.1.2 Preparation Date
Date 510(k) Summary Prepared:
2.1.3 Device Name
Trade or Proprietary Name: Vitros Immunodiagnostic Products HBsAg Controls
HBsAg Controls Common Name:
Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).
2.1.4 Predicate Device
The Vitros Immunodiagnostic Products HBsAg Controls are substantially equivalent to Ortho-Clinical Diagnostics, Inc. Vitros Immunodiagnostic Products HBsAg Controls (K011250).
1
Device Description 2.1.5
The Vitros Immunodiagnostic System uses luminescence as the signal in the qualitative detection of HBsAg in human plasma and serum. Coated microwells are used as the solid phase separation system.
The system is compromised of three main elements:
- The Vitros Immunodiagnostic Products range of products, in this case 1. Vitros Immunodiagnostic Products HBsAg Reagent Pack and Vitros Immunodiagnostic Products Calibrator, which are combined by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator have been approved for sale (PMA P000044).
- The Vitros Immunodiagnostic System- instrumentation, which provides 2. automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared be market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the Vitros System in each assay. The Vitros 3. Immunodiagnostic Products Signal Reagent and the Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).
The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.
Device Intended Use 2.1.6
The Vitros Immunodiagnostic Products HBsAg Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, heparin or citrate). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.
2
Comparison to Predicate Device 2.1.7
The Vitros Immunodiagnostic Products HBsAg Controls are substantially equivalent to Ortho-Clinical Diagnostics Inc. Vitros Immunodiagnostic Products HBsAg Controls (K011250)
Table 1 lists the characteristics of the Vitros Immunodiagnostic Products HBsAg Controls (new device) and the Vitros Immunodiagnostic Products HBsAg Controls (predicate device).
3
| Device
Characteristic | Vitros
Immunodiagnostic
Products HBsAg
Controls
(New device) | Vitros
Immunodiagnostic
Products HBsAg
Controls
(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 Hepatitis B
Surface Antigen (HBsAg)
in human serum and
plasma (EDTA, citrate
and heparin). The
performance of the Vitros
Immunodiagnostic
Products HBsAg Controls
has not been established
with any other HBsAg
assays. | For use in monitoring the
performance of the Vitros
ECi Immunodiagnostic
System when used for the
in vitro qualitative
detection of Hepatitis B
Surface Antigen (HBsAg)
in human serum. The
performance of the Vitros
Immunodiagnostic
Products HBsAg Controls
has not been established
with any other HBsAg
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 | Positive and negative | 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 | 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
Summary of Assessment of Performance Data 2.1.8
The new device is the same as the predicate device with the addition of data that supports a modification in the Intended Use. Additional data demonstrate the use of the controls to assess the performance of the Vitros Immunodiagnostic Products HBsAg assay when determining the qualitative
4
detection of HBsAg in human plasma (EDTA, citrate and heparin) in addition to serum. Included in this 510(k) submission is the technical report that describes the assessment of multiple samples collected as either whole serum or in the presence of EDTA citrate or heparin. Each sample was tested either unspiked (negative) or spiked with known positive HBsAg plasma close to the weak positive detection level of the assay (positive). The results showed that all samples (serum, EDTA, citrate or heparin) behave similarly in the assay supporting that the controls can monitor the assay performance regardless of the tested sample matrix (serum or plasma).
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are simple and abstract, with smooth lines suggesting the shape of a head and face. The profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2003
Ms. Sarah Parsons Associate, Regulatory Affairs Ortho-Clinical Diagnostics. Inc. Regulatory Affairs MC00882 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K030067
Trade/Device Name: Vitros Immunodiagnostic Products HBsAg Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I Product Code: MJX Dated: January 6, 2003 Received: January 7, 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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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 Putman
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
7
3.0 SUMMARY INFORMATION
Statement of Intended Use 3.1
Page 1 of 1
KU 30067 510(k) Number (if known):
Vitros Immunodiagnostic Products HBsAg Controls
Indications for Use:
Device Name:
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.
For in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie Lu. Poole
n of Clinical Laboratory Devices
510(k) Number K030067
Prescription Use
OR
Over-The-Counter Use _
Ortho-Clinical Diagnostics, Inc.