(86 days)
K 020801
Not Found
No
The device description details a standard immunoassay based on chemical reactions and visual interpretation of bands, with no mention of computational analysis, algorithms, or learning processes.
No
This device is a diagnostic test for the early detection of pregnancy, not a therapeutic device designed to treat or cure a condition.
Yes
Explanation: The device is intended for the qualitative detection of human chorionic gonadotropin (hCG) for the early detection of pregnancy, which is a diagnostic purpose to identify a physiological condition.
No
The device description clearly outlines a physical immunoassay test kit with a sample well, reaction pads, membrane, and results window, indicating it is a hardware-based diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human chorionic gonadotropin (hCG)... in urine or serum for the early detection of pregnancy." This describes a test performed on samples taken from the human body to provide information about a physiological state (pregnancy).
- Device Description: The description details a "rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum." This further confirms it's a test performed on biological samples.
- Sample Type: The test uses "urine or serum," which are biological specimens.
- Purpose: The purpose is "for the early detection of pregnancy," which is a diagnostic purpose.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state or a congenital abnormality.
N/A
Intended Use / Indications for Use
The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.
Product codes
JHI
Device Description
The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).
The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.
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
physicians' offices and clinical laboratories.
health care professionals.
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)
A total of 201 urine samples and 319 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. When tested according to the instructions and limits in the package inserts, the results obtained with the different assays were in agreement with the exception of two discrepant samples. One urine sample and one serum sample produced positive responses with the QuickVue® One-Step Combo hCG test while the Contrast® II Urine/Serum test produced negative results for those samples. The discrepant samples were tested with a quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) and found to contain 2.6 mIU hCG/mL in the urine sample and 0 mIU hCG/mL in the serum sample.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: Urine: 20 mIU/mL; Serum: 10 mIU/mL
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.
K 020801
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.
Not Found
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
§ 862.1155 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
JAN 1 6 2003
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the Contrast® II hCG Urine/Serum test.
-
- Sponsor/Applicant Name and Address:
Genzyme Corporation One Kendall Square Cambridge, MA 02139
- Sponsor/Applicant Name and Address:
-
- Sponsor Contact Information:
E.V. Goorchenko Associate Director, Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com
- Sponsor Contact Information:
-
- Date of Preparation of 510(k) Summary: October 21, 2002
-
- Device Trade or Proprietary Name:
Contrast® II hCG Urine/Serum Test
-
- Device Common/Usual or Classification Name:
hCG Test System
- Device Common/Usual or Classification Name:
-
- Legally Marketed Devices to which Equivalence is Being Claimed:
Quidel QuickVue® One-Step hCG Combo Test (K 020801)
- Legally Marketed Devices to which Equivalence is Being Claimed:
1
7. Device Description
Intended Use
The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
Principle of the Device
The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).
The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.
8. Comparison of Technological Characteristics of Genzyme Contrast® II hCG Urine/Serum Test with Legally Marketed Device:
The similarities with, and differences between, the Contrast® II hCG Urine/Serum test and the Quidel One-Step device are described in Table 1.
Agreement with Predicate Device: 9.
A total of 201 urine samples and 319 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. When tested according to the instructions and limits in the package inserts, the results obtained with the different assays were in agreement with the exception of two discrepant samples. One urine sample and one serum sample produced positive responses with the QuickVue® One-Step Combo hCG test while the Contrast® II Urine/Serum test produced negative results for those samples. The discrepant samples were tested
2
with a quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) and found to contain 2.6 mIU hCG/mL in the urine sample and 0 mIU hCG/mL in the serum sample.
| | Genzyme Contrast® II hCG
Urine/Serum Test | Quidel
QuickVue® hCG-Combo Test |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Result Format | Visible lines:
Negative=one gray or black
Control Line
Positive=one gray or black
Control Line and one gray or
black Test Line | Visible lines:
Negative =blue procedural
Control Line
Positive = one pink-to-purple
Test Line and one blue Control
Line |
| Specimen | Urine or Serum | Urine or Serum |
| Antibodies | Mouse monoclonal and
goat polyclonal | Mouse monoclonal and
goat polyclonal |
| Internal Control | Yes | Yes |
| Time
To
Result | Urine: Read result at 3
minutes
Serum: Read result at 5 or 7
minutes | Urine: Read result at 3 minutes
Serum: Read result at 5
minutes |
| Analytical Sensitivity | Urine: 20 mIU/mL
Serum: 10 mIU/mL | Urine: 20 mIU/mL
Serum: 10 mIU/mL |
Table 1. Summary of Device Similarities and Differences
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 6 2003
Mr. E. V. Goorchenko Associate Director, Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, MA 02139
Re: K023544
Trade/Device Name: Contrast ® II hCG Urine/Serum Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: October 21, 2002 Received: October 22, 2002
Dear Mr. Goorchenko:
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. Iisting 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 Butman
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
5
510(k) Number: New Application Ko23544
Device Name :
Contrast® II hCG Urine/Serum Test
Indications for Use:
The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
k) Number K023544
✓
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)