(115 days)
No
The summary describes a standard immunoassay system and does not mention any AI or ML components.
No
This device is for in vitro diagnostic (IVD) use, specifically for quantitative measurement of hCG to aid in early detection of pregnancy, not for therapy.
Yes
The device quantitatively measures human chorionic gonadotropin (hCG) to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device description clearly outlines hardware components (VITROS Immunodiagnostic System - instrumentation, coated microwells) and reagents, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma... to aid in the early detection of pregnancy." This clearly indicates the device is used to test human samples in vitro (outside the body) for diagnostic purposes (aiding in pregnancy detection).
- Device Description: The description details an "Immunodiagnostic System" that uses immunoassay products to measure analytes in "human body fluids, commonly serum and plasma." This further confirms its use with biological samples in vitro.
- Calibration and Verification: The intended use also includes calibration and verification of the system for measuring hCG in human serum and plasma, which are activities directly related to ensuring the accuracy of an in vitro diagnostic test.
The entire description points to a system designed to perform tests on human biological samples in a laboratory setting, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack For quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.
VITROS Immunodiagnostic Products Total ß-hCG II Calibrators For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.
Product codes
DHA, JIT, JJX
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 assay is comprised of three main elements:
-
The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack, the VITROS Immunodiagnostic Products Total B-hCG II Calibrators, and the VITROS Immunodiagnostic Products Total B-hCG II Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS Total B-hCG II 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 Immunodiagnostic System in each assay include 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 B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics mentioned:
Analytical Sensitivity: 0.70 mIU/mL
Specificity: ≤ 10% for FSH, LH and TSH
Precision: Within-Run (CV 1.1-2.5%), Within-lab (2.9-4.2%)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
510(k) Summary I
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.
K063720 The assigned 510(k) number is: _
Submitter Name, Address and Contact 1
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-4131
Contact Person: Sarah CV Parsons, RAC
Preparation Date 2
Date 510(k) prepared: December 14, 2006
3 Device Name
VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack VITROS Immunodiagnostic Products Total β-hCG II Calibrators VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers
Common Name: Total ß-hCG II Assay
Classification Name(s): Human chorionic gonadotropin (HCG) test system (21 CFR 862.1155) Calibrators (21 CFR 862.1150) Ouality Control material (assayed and unassayed) (21 CFR 862.1660)
Classifications: The Clinical Chemistry and Toxicology Panel of the FDA has placed the Human chorionic gonadotropin (HCG) test system as a Class II Medical Device. The Microbiology Device Panel has classified Calibrators as Class II Medical Devices (21 CFR 862.1150). The Microbiology Device Panel has classified Controls as Class I Medical Devices (21 CFR 862.1660)
Product Code: DHA, JIT, JJX
1
Manufacturing Establishment 9680658 Registration Number:
Ortho Clinical Diagnostics, Inc. Manufacturer Site: Forest Farm Estate Cardiff United Kingdom CF14 7YT
Predicate Device 4
Ortho-Clinical Diagnostics, Inc. believes that the VITROS Immunodiagnostic Products Total B-hCG II assay and VITROS Immunodiagnostic Products Total BhCG II Range Verifiers are substantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total ß-HCG assay (K983424) and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers (K970894).
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 assay is comprised of three main elements:
-
The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack, the VITROS Immunodiagnostic Products Total B-hCG II Calibrators, and the VITROS Immunodiagnostic Products Total B-hCG II Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS Total B-hCG II 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 Immunodiagnostic System in each assay include 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 B-hCG Reagent Pack and VITROS
2
Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Device Intended Use 6
VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack For quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.
VITROS Immunodiagnostic Products Total ß-hCG II Calibrators For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ßsubunit in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.
7 Comparison to Predicate Device
Ortho-Clinical Diagnostics, Inc. believes that the VITROS Immunodiagnostic Products Total B-hCG II assay and VITROS Immunodiagnostic Products Total BhCG II Range Verifiers are substantially equivalent to the Abbott Laboratories, ARCHITECT® SYSTEM Total B-HCG assay (K983424) assay and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers (K973517). Tables 1 through 4 compare the VITROS Immunodiagnostic Products Total 3hCG II assay and Range Verifiers to the Abbott Laboratories, ARCHITECT® SYSTEM Total B-HCG II assay and VITROS Immunodiagnostic Products Total B-hCG Range Verifiers.
3
Table 1 Comparison of the VITROS Immunodiagnostic Products Total βhCG II assay to the Abbott Laboratories, ARCHITECT® SYSTEM Total β-HCG assay: Similarities
| Similarities | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Characteristic | New device | Predicate device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Use | For the quantitative measurement of human | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| chorionic gonadotropin (hCG) and its β-subunit in | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| human serum and plasma (EDTA and heparin) | ... for the quantitative and qualitative determination | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| of beta-human chorionic gonadotropin (β-hCG) in | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| human serum and plasma ... | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| principle | chemiluminescent immunometric assay | Chemiluminescent Microparticle Immunoassay | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Antibody | conjugated monoclonal mouse anti-β-hCG | Conjugated monoclonal mouse anti-β-hCG | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sample | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| type | Serum and Plasma (EDTA and heparin) | Serum and Plasma (EDTA and heparin) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Expected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Values | LMP n Min Max 2.5 97.5 1-10 112 44.71 256,740 63.7 150,854 11-15 43 11,556 265,380 11,795 151,996 16-20 50 7,480.8 111,954 9,383.8 61,410 23-40 45 1,531.1 101,566 1,737.2 98,576 | LMP n Min Max 2.5 97.5 1-10 50 225,000.00 201.6 >225,000.00 11-1 50 16,995.65 >225,000.00 22,536.49 >225,000.00 16-20 50 8,860.23 >225,000.00 8,006.62 50,238.60 23-40 50 1,583.40 65,911.30 1,599.80 49,412.65 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Measuring | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Range | Up to 15,000 mIU/mL | Up to 15,000 mIU/mL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Precision | Within-Run (CV 1.1-2.5%), Within-lab (2.9-4.2%) | Within-Run (CV 1.2-4.7%), Total (CV 1.6-4.9%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analytical | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sensitivity | 0.70 mIU/mL | ≤ 1.2 mIU/mL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Specificity | ≤ 10% for FSH, LH and TSH | ≤ 10% for FSH, LH and TSH |
4
Comparison of the VITROS Immunodiagnostic Products Total ß-Table 2 hCG II assay to the Abbott Laboratories, ARCHITECT® SYSTEM Total ß-HCG assay: Differences
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | New device | Predicate device |
| Intended Use | Indication not in statement. | ... for the early detection of pregnancy |
| Sample volume | 40 $ \mu $ L | 75 $ \mu $ L |
| Antibodies | Biotin conjugated mouse | |
| monoclonal anti- $\beta$ -hCG | Mouse monoclonal anti- $\beta$ -hCG coated | |
| microparticles. | ||
| Luminescent label | Horse radish peroxidase | acridinium |
| Instrumentation | VITROS Immunodiagnostic | |
| System | ARCHITECT SYSTEM | |
| Calibrator levels | Three levels | Six levels |
Comparison of the VITROS Immunodiagnostic Products Total β-Table 3 hCG II Range Verifiers to the VITROS Immunodiagnostic Products Total ß-hCG Range Verifiers: Similarities
| Similarities | |||||
|---|---|---|---|---|---|
| Device | |||||
| Characteristic | New device | Predicate device | |||
| Intended Use | For in vitro use in verifying the | ||||
| calibration range of the VITROS | |||||
| Immunodiagnostic System when | |||||
| used for the measurement of | |||||
| human chorionic gonadotropin | |||||
| (hCG) and its ß-subunit | For in vitro use in verifying the | ||||
| calibration range of the VITROS | |||||
| Immunodiagnostic System when | |||||
| used for the measurement of human | |||||
| chorionic gonadotropin (hCG) and | |||||
| its ß-subunit | |||||
| Levels | Low and High | Low and High | |||
| Format | Freeze-dried | Freeze-dried |
Comparison of the VITROS Immunodiagnostic Products Total β-Table 4 hCG II Range Verifiers to the VITROS Immunodiagnostic Products Total β-hCG Range Verifiers: Differences
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | New device | Predicate device |
| Matrix | Human plasma | Bovine serum |
| Antigen | Bacterial Recombinant hCG | Purified from human urine hCG |
5
8 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Total B-hCG II Reagent Pack, VITROS Total ß-hCG II Calibrator and VITROS Total ß-hCG II Range Verifiers are safe and effective for the stated intended uses and is substantially equivalent to the cleared predicate devices.
The VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and the VITROS Immunodiagnostic Products Total β-hCG II Calibrator were compared to the Abbott Laboratories, ARCHITECT® SYSTEM Total β-HCG assay. The VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers were compared to the VITROS Immunodiagnostic Products Total ß-hCG Range Verifiers.
6
Image /page/6/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.
2098 Gaither Road
Rockville MD 20850
Food and Drug Administration
APR - 9 2007
Ms. Sarah CV Parsons, RAC Ortho-Clinical Diagnostics, Inc. Regulatory Affairs, MC00881 100 Indigo Creek Drive Rochester, NY 14626-5101
Re: K063720
Trade/Device Name: Vitros Immunodiagnostic Products Total B-HCG II reagent PA Vitros Immunodiagnostic Products Total B-HCG II Calibrators Vitros Immunodiagnostic Products Total B-HCG II Range Verifiers Regulation Number: 21 CFR § 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, JIT, JJX Dated: March 26, 2007 Received: March 27, 2007
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).
7
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 (240) 276-0490. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use 1
Page 1 of 1
510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack VITROS Immunodiagnostic Products Total B-hCG II Calibrators VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers
Indications for
Use:
For quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin).
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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
b63720