(124 days)
Quidel QuickVue®+ One-Step hCG Combo Test (K)
Not Found
No
The device description details a traditional immunochromatographic assay based on antibody binding and visual interpretation of bands. There is no mention of computational analysis, algorithms, or learning processes.
No.
This device is for diagnostic purposes (detection of hCG to aid in early detection of pregnancy), not for treating or preventing a disease or condition.
Yes
The device is described as aiding in the "early detection of pregnancy" by detecting hCG, which is a diagnostic purpose.
No
The device description clearly outlines a physical immunochromatographic assay with components like reaction pads, a membrane, and a results window, indicating it is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy." This involves testing biological samples (urine or serum) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "solid phase, sandwich-format immunochromatographic assay." This is a common method used in IVD tests to detect specific substances in biological samples.
- Sample Type: The test uses "urine or serum," which are biological specimens.
- Care Setting: The intended use in "physicians' offices and clinical laboratories" are typical settings where IVD tests are performed.
- Performance Studies: The document describes performance studies comparing the device to a "currently marketed qualitative hCG assay," which is a predicate device, a common requirement for IVD regulatory submissions.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Genzyme Diagnostics OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
Product codes
JHI
Device Description
The OSOM hCG Combo 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 Pipette® 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 hCG complex is captured at a test line region containing immobilized rabbit 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.
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)
Agreement with Predicate Device:
A total of 634 urine samples and 691 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. The agreement for the OSOM urine procedure, on both positive and negative samples, was >99% and, for the OSOM serum procedure, agreement on both positive and negative samples was >99%.
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.
Quidel QuickVue®+ One-Step hCG Combo Test (K)
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
K 043385
510(k) SUMMARY
APR 1 2 2005
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 OSOM hCG Combo test.
-
Sponsor/Applicant Name and Address: 1.
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 -
Sponsor Contact Information: 2.
E.V. Goorchenko Director of Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com -
Date of Preparation of 510(k) Summary: 3. February 22, 2005
-
Device Trade or Proprietary Name: 4.
OSOM hCG ComboTest
- Device Common/Usual or Classification Name: 5.
hCG Test System
1
Legally Marketed Devices to which Equivalence is Being Claimed: 6.
Quidel QuickVue®+ One-Step hCG Combo Test (K)
Device Description 7.
Intended Use
The Genzyme Diagnostics OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
Principle of the Device
The OSOM hCG Combo 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 Pipette® 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 hCG complex is captured at a test line region containing immobilized rabbit 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.
2
Comparison of Technological Characteristics of OSOM hCG Combo with 8. Legally Marketed Device:
The similarities with, and differences between, the OSOM hCG Combo test and the Quidel QuickVue®+ One-Step device are described in Table 1.
Agreement with Predicate Device: 9.
A total of 634 urine samples and 691 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. The agreement for the OSOM urine procedure, on both positive and negative samples, was >99% and, for the OSOM serum procedure, agreement on both positive and negative samples was >99%.
| | Genzyme OSOM hCG
Combo 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 =two blue lines
Positive = one pink line
and two blue lines. |
| Specimen | Urine or Serum | Urine or Serum |
| Antibodies | Mouse monoclonal and
rabbit polyclonal | Mouse monoclonal and
goat polyclonal |
Table 1. Summary of Device Similarities and Differences
3
| Internal Control | Yes | Yes |
|---|---|---|
| Time | ||
| To | ||
| Result | Urine: Read result at 3 | |
| minutes | ||
| Serum: Read result at 5 | ||
| 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 |
4
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
APR 】 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gene Goorchenko Director of Regulatory Affairs Genzyme Diagnostics 6659 Top Gun Street San Diego, CA 92121
K043385 Re:
Trade/Device Name: OSOM hCG Combo Regulation Number: 21 CFR 862.1155 Regulation Name: Urinary pH (nonquantitative ) test system Regulatory Class: Class II Product Code: JHI Dated: March 18, 2005 Received: March 21, 2005
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, 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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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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, 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
6
Indications for Use
510(k) Number: K
510(k) Number:
Device Name: OSOM hCG Combo
Indications for Use: The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
Prescription Use (Part 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 Device Evaluation (ODE)
Division Sign Off
Division /Sign-Off
Office of In Vitro Diagn Device Evaluation an
510(k) K093385
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