(177 days)
P790019, K974613
No
The description details a standard immunoassay system and methodology, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human serum or plasma. It is used to diagnose acute or recent hepatitis A, not to provide therapy or treatment.
Yes
The intended use explicitly states, "The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A." This clearly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a system comprised of hardware (VITROS Immunodiagnostic System instrumentation) and physical reagents (reagent packs, calibrators, common reagents). The assay itself is a chemical reaction measured by luminescence, not purely software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma..." and "For in vitro use in the calibration..." and "For in vitro use in monitoring the performance...". The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the device analyzes human body fluids (serum and plasma) using an immunoassay to detect a specific analyte (anti-HAV IgM). This is a typical function of an IVD.
- Performance Studies: The document includes performance data based on testing human samples, which is required for IVDs to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Devices: The mention of predicate devices (P790019 IMX HAVAB-M assay and K974613 Blackhawk BioSystems, Inc Virotrol III) which are also IVDs, further supports that this device falls into the same category.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITROS Anti-HAV IgM Reagent Pack: For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A.
VITROS Anti-HAV IgM Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative determination of IgM antibody to hepatitis A viral antigen (HAV) in human serum and plasma (EDTA, heparin or citrate.
VITROS Anti-HAV IgM Controls For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of anti-HAV IgM.
Product codes (comma separated list FDA assigned to the subject device)
LOL
Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: - The VITROS Immunodiagnostic Products range of immunoassay . products (in this case the VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack and the VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators) and VITROS Immunodiagnostic Products High Sample Diluent B which are combined by the VITROS Immunodiagnostics System to perform the VITROS Anti-HAV IgM assay. - The VITROS Immunodiagnostic System instrumentation, which . provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for 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 VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total β-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Anti-HAV IgM assay utilizes an antibody class capture assay design, for the measurement of IgM antibodies to hepatitis A antigen, in human serum or plasma. The assay involves dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal anti-human IgM antibody. The immune complex is captured by streptavidin on the wells, unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HAV antibody that has been complexed with inactivated HAV antigen (conjugate) is then captured by anti-HAV specific IgM bound to the wells. Unbound material is removed by washing. Enzyme substrate is then added and bound HRP conjugate is measured by a luminescent reaction. He binding of HRP conjugate is indicative of the presence of anti-HAV IgM.
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
Adult and pediatric
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)
Precision was tested across three sites demonstrating total precision of a sample near the assay cutoff to be 13.2%. Precision of serum and plasma were also assessed supporting that there is no substantial difference based on samples matrix. A variety of common interferents and potential cross reactive subgroup were tested supporting that the samples do not interfere with the assay.
Expected results of the VITROS Anti-HAV IgM assay to detect IgM in presumably healthy individuals were determined from a US population residing in areas of high (Western, US) and low (Eastern US) HAV disease prevalence. The population represented the typical demographics of age, gender and race representative of the United States.
A multi-center study was conducted to establish the performance characteristics of the VITROS Anti-HAV IgM assay using samples obtained in the U.S. and India from individuals at high risk for hepatitis and/or with signs or symptoms of hepatitis.
The overall positive percent agreement among the combined prospectively collected samples was 100.0% (32/32). The overall negative percent agreement was 99.74% (1156/1159).
The VITROS Anti-HAV IgM assay was also positive in 100.0% (77/77) of samples from subjects known to be anti-HAV IgM reactive, and negative in 100.0% (110/110) of samples from pediatric subjects at low risk for hepatitis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The overall positive percent agreement among the combined prospectively collected samples was 100.0% (32/32). The overall negative percent agreement was 99.74% (1156/1159).
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.
P790019, K974613
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
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.
0
CONFIDENTIAL AND PROPRIETARY
SECTION 5: 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: ڪرڪ 0 770
1 Submitter Name, Address and Contact
Ortho-Clinical Diagnostics, Inc. MC 881 100 Indigo Creek Drive Rochester. New York 14626-5101 (585) 453-3154
Contact Person: Sarah Parsons, RAC
2 Preparation Date
Date 510(k) prepared: March 20, 2006
3 Device Name
VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators VITROS Immunodiagnostic Products Anti-HAV IgM Controls
Common Name: Anti-HAV IgM Assay Anti-HAV IgM Controls
Classification Name: Hepatitis A virus (HAV) serological assays (866.3310)
Single (specified) analyte controls (assayed and unassayed (862.1660
Assay Class: II special controls Controls Class: I
1
4 Predicate Device
The VITROS Immunodiagnostic Products Anti-HAV IgM assay is substantially equivalent to the IMX HAVAB-M assay (PMA P790019).
The VITROS Immunodiagnostic Products Anti-HAV IgM Controls is substantially equivalent to Blackhawk BioSystems, Inc Virotrol III (K974613).
5 Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay . products (in this case the VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack and the VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators) and VITROS Immunodiagnostic Products High Sample Diluent B which are combined by the VITROS Immunodiagnostics System to perform the VITROS Anti-HAV IgM assay.
- The VITROS Immunodiagnostic System instrumentation, which . provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for 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 VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total β-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
2
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
The VITROS Anti-HAV IgM assay utilizes an antibody class capture assay design, for the measurement of IgM antibodies to hepatitis A antigen, in human serum or plasma. The assay involves dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal anti-human IgM antibody. The immune complex is captured by streptavidin on the wells, unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HAV antibody that has been complexed with inactivated HAV antigen (conjugate) is then captured by anti-HAV specific IgM bound to the wells. Unbound material is removed by washing. Enzyme substrate is then added and bound HRP conjugate is measured by a luminescent reaction. He binding of HRP conjugate is indicative of the presence of anti-HAV IgM.
6 Device Intended Use
VITROS Anti-HAV IgM Reagent Pack:
For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System.
VITROS Anti-HAV IgM Calibrator
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative determination of IgM antibody to hepatitis A viral antigen (HAV) in human serum and plasma (EDTA, heparin or citrate.
VITROS Anti-HAV IgM Controls
For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of anti-HAV IgM.
7 Comparison to Predicate Device
The VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack and VITROS Immunodiagnostic Products Calibrators are substantially equivalent to Abbott IMX HAVAB-M assay which was cleared by FDA (P790019) for IVD use.
3
The VITROS Immunodiagnostic Products Anti-HAV IgM Controls are substantially equivalent to Blackhawk BioSystems, Inc Virotrol III which was cleared by FDA (K974613) for IVD use.
4
and the same of the same of the same of the same of the same of the same of
Comparison of the VITROS Immunodiagnostic Products Table 1 Anti-HAV IgM assay to the IMX HAVAB-M assay: Similarities
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | Predicate Device |
| Intended Use | For the qualitative | |
| determination of IgM | ||
| antibody to hepatitis A | ||
| virus (anti-HAV IgM)... | For the qualitative | |
| determination of specific | ||
| IgM antibody against | ||
| hepatitis A virus (IgM Anti- | ||
| HAV) | ||
| Basic principle | Enzyme Linked Immuno | |
| Assay | Enzyme Linked Immuno | |
| Assay | ||
| Antigen | Hepatitis A virus | Hepatitis A virus |
| Antibody | Monoclonal antibody: | |
| Mouse anti-HAV | Monoclonal antibody: | |
| Mouse anti-HAV | ||
| Instrumentation | ECI/ECIQ | |
| Immunodiagnostic | ||
| System: Automated | ||
| analyzer | IMX System: Automated | |
| analyzer | ||
| Sample type | Serum, plasma (heparin, | |
| citrate, EDTA) | Serum, plasma (heparin, | |
| citrate, EDTA) |
Table 2 Comparison of the VITROS Immunodiagnostic Products Anti-HAV IgM assay to the IMX HAVAB-M assay: Differences
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | Predicate Device |
| Antibody | Mouse anti-Human IgM | Goat anti-Human IgM |
| Tracer | Horseradish Peroxidase | Alkaline Phosphatase |
| Sample volume | 10µL | 150µL |
5
Table 3 Comparison of the VITROS Immunodiagnostic Products Anti-HAV IgM Controls to the Blackhawk BioSystems, Inc Virotrol III Controls: Similarities
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | Predicate Device |
| Intended Use | For in vitro use in | |
| monitoring the | ||
| performance of the | ||
| VITROS | ||
| Immunodiagnostic | ||
| System when used for | ||
| the detection of anti- | ||
| HAV IgM. | ... determination of | |
| immunoglobulin M | ||
| antibodies to Hepatitis A | ||
| Virus (HAV-IgM)... | ||
| Matrix of controls | Human plasma and | |
| antimicrobial agents | Human serum with added | |
| human proteins and | ||
| antimicrobial agents | ||
| Control level | Positive and negative | Positive |
Table 4 Comparison of the VITROS Immunodiagnostic Products Anti-HAV IgM Controls to the Blackhawk BioSystems, Inc Virotrol III Controls: Differences
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | Predicate Device |
| Intended use | Only Anti-HAV IgM is | |
| detected in the positive | ||
| control. | Both anti-HAV and anti- | |
| HBV IgM antibodies are | ||
| included in the control | ||
| 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. | There is no assigned value. | |
| The VIROTROL III | ||
| reagents have been designed | ||
| to produce a positive | ||
| reaction when used in the | ||
| proper manner with many | ||
| commercial test kits. Levels | ||
| of reactivity and specific | ||
| performance characteristics | ||
| will vary with different | ||
| manufacturers' kits and | ||
| assay procedures. |
6
Summary of Performance
Precision was tested across three sites demonstrating total precision of a sample near the assay cutoff to be 13.2%. Precision of serum and plasma were also assessed supporting that there is no substantial difference based on samples matrix. A variety of common interferents and potential cross reactive subgroup were tested supporting that the samples do not interfere with the assay.
Expected results of the VITROS Anti-HAV IgM assay to detect IgM in presumably healthy individuals were determined from a US population residing in areas of high (Western, US) and low (Eastern US) HAV disease prevalence. The population represented the typical demographics of age, gender and race representative of the United States.
A multi-center study was conducted to establish the performance characteristics of the VITROS Anti-HAV IgM assay using samples obtained in the U.S. and India from individuals at high risk for hepatitis and/or with signs or symptoms of hepatitis.
The overall positive percent agreement among the combined prospectively collected samples was 100.0% (32/32). The overall negative percent agreement was 99.74% (1156/1159).
The VITROS Anti-HAV IgM assay was also positive in 100.0% (77/77) of samples from subjects known to be anti-HAV IgM reactive, and negative in 100.0% (110/110) of samples from pediatric subjects at low risk for hepatitis.
8 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Anti-HAV IgM assay and VITROS Anti-HAV IgM controls are safe and effective for the stated intended uses and is substantially equivalent to the cleared predicate devices.
The VITROS Immunodiagnostic Products Anti-HAV IgM assay was compared to the Abbott IMX HAVAB-M assay testing commercially available reagents and human samples.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EP 1 5 2006
Ms. Sarah CV Parsons Manager, Regulatory Affairs Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive MC0881 Rochester, NY 14626-5101
K060770 Re:
Trade/Device Name: VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators VITROS Immunodiagnostic Products Anti-HAV IgM Controls Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: Class II Product Code: LOL Dated: August 3, 2006 Received: August 4, 2006
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).
8
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 (240)276-0450. 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,
Sally, attorn
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
9
SECTION 4: INDICATIONS FOR USE STATEMENT
Page 1 of 1
260770 510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators
VITROS Immunodiagnostic Products Anti-HAV IgM Controls
Indications for Use:
VITROS Anti-HAV IgM Reagent Pack:
For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System.
The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A.
VITROS Anti-HAV IgM Calibrator
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative determination of IgM antibody to hepatitis A viral antigen (HAV) in human serum and plasma (EDTA, heparin or citrate.
VITROS Anti-HAV IgM Controls
For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of anti-HAV IgM.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| Ortho-Clinical Diagnostics, Inc. | Section 4, Page 1 of 1 | March 20 |
|---|---|---|
| 510(k) | K060770 |
0, 2006