(40 days)
Not Found
No
The device description and performance studies focus on a traditional immunoassay method using antibodies, with no mention of AI/ML or related concepts like image processing or training/test sets for algorithmic development.
No.
The device is used for the qualitative detection of human chorionic gonadotropin (hCG) for the early determination of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as "The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy," which directly indicates its purpose is to diagnose pregnancy.
No
The device description clearly states it is a "Rapid membrane based immunoassay," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy". This involves testing biological samples (urine or serum) in vitro (outside the body) to provide diagnostic information (pregnancy determination).
- Device Description: The description mentions a "Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies." Immunoassays are a common type of IVD test.
- Care Setting: The intended user/care setting is "physician's office and clinical laboratories," which are typical environments where IVD tests are performed.
- Performance Studies: The description of performance studies involves testing "coded serum specimens, spiked with hCG at different levels," which is characteristic of validating an IVD test's performance.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician's office and clinical laboratories.
Product codes
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Device Description
Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.
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
physician's office and clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A multicenter sensitivity and reproducibility study was performed in three physician's offices/clinics (POL). The legally marketed Genzyme Diagnostics Rapid hCG™ Urine/Serum Test was provided to the sites. Coded serum specimens, spiked with hCG at different levels, were provided to all sites. Tests were performed in triplicate on each of three different days. Results indicated the Genzyme Diagnostics Rapid hCG" Urine/Serum Test can detect 10 mIU/mL hCG in serum at 7 minutes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
NOV 25 1996
510(k) Notification Genzyme Diagnostics Contrast® |Rapid™ hCG October 15, 1996
510(k) Summary of Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Made
| Trade or Proprietary Name: | Contrast ® hCG Urine/Serum Test
Rapid hCG™ hCG Urine/Serum Test |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Human Chorionic Gonadotropin Test System |
| Product Classification Number: | 21 CFR § 862.1155, Class II |
| Manufacturer: | Genzyme Diagnostics
1531 Industrial Road
San Carlos, CA 94070 |
| Contact Person: | Delia R. Bethell, Ph.D.
Director of Research and Development
Phone:
(415) 594-0513
Fax:
(415) 594-0571 |
| Equivalence Device: | Rapid hCG™ Urine/Serum Test
510(k) Number: K952319
Cleared June 20, 1995 |
| Device Description: | Rapid membrane based immunoassay for the qualitative
detection of hCG using mouse monoclonal anti-hCG and
sheep anti-alpha hCG polyclonal antibodies. |
| Intended Use: | The qualitative detection of human chorionic gonadotropin
(hCG) in urine or serum for the early determination of
pregnancy for use in the physician's office and clinical
laboratories. |
A multicenter sensitivity and reproducibility study was performed in three physician's offices/clinics (POL). The legally marketed Genzyme Diagnostics Rapid hCG™ Urine/Serum Test was provided to the sites. Coded serum specimens, spiked with hCG at different levels, were provided to all sites. Tests were performed in triplicate on each of three different days. Results indicated the Genzyme Diagnostics Rapid hCG" Urine/Serum Test can detect 10 mIU/mL hCG in serum at 7 minutes.
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