(40 days)
Not Found
No
The device description and performance studies describe a standard immunoassay test strip, with no mention of AI or ML.
No.
The device is for the detection of hCG for early determination of pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or prevent any condition.
Yes
This device is intended for the "qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy," which is a diagnostic purpose.
No
The device description explicitly states it is a "Rapid membrane based immunoassay," which is a physical test strip, 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 a biological sample (urine or serum) in vitro (outside the body) to obtain diagnostic information.
- Device Description: It describes 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.
- Sample Type: The device uses "human serum or urine," which are biological specimens tested in vitro.
- Care Setting: It is intended for use in "physician's office and clinical laboratories," which are settings where IVD testing is performed.
All of these factors align with the definition 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 in physician's office and clinical laboratories. The intended use of the Genzyme Diagnostics Contrast® Strip hCG is the early determination of pregnancy by the qualitative detection of human chorionic gonadotropin (hCG) in human serum or urine. Our intent is to market this product for laboratory and professional use.
Product codes
21 CFR § 862.1155
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. laboratory and professional use.
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
A multicenter clinical study was performed in four physician's offices/clinics (POL). The Genzyme Diagnostics Contrast" Strip hCG was provided to the sites. Each site also used the legally marketed Rapid hCG™ Urine/Serum Test. The Rapid hCG™ Urine/Serum Test is marketed for laboratory and professional use. Urine specimens were tested in four physician's offices using both Genzyme tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, post-menopausal women and assumed negatives. Three physician's offices performed both Genzyme tests on serum specimens from female patients for either confirmation of pregnancy or non-pregnancy status prior to treatment (e.g. X-ray) for other disease states and post-menopausal women.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multicenter clinical study was performed in four physician's offices/clinics (POL). The Genzyme Diagnostics Contrast" Strip hCG was provided to the sites. Each site also used the legally marketed Rapid hCG™ Urine/Serum Test. The Rapid hCG™ Urine/Serum Test is marketed for laboratory and professional use. The results with both urine (209) and serum (177) samples demonstrate that the Genzyme Diagnostics Contrase Strip hCG has 100% agreement with the Rapid hCG™ Urine/Serum Test. At three POLs, eight individuals with various levels of training tested a blind reproducibility and sensitivity panel using the Genzyme Diagnostics Contrast® Strip hCG. The Genzyme Diagnostics Contrast® Strip hCG reproducibly detected hCG in urine at levels as low as 20 mIU/mL and as high as 1,000,000 mIU/mL and serum hCG at levels as low as 10 mIU/mL and as high as 1,000,000 mIU/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The Genzyme Diagnostics Contras® Strip hCG Test can detect hCG concentrations of 20 mIU/mL in urine and 10 mIU/mL in serum.
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.
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
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® Strip 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 Strip hCG |
|---|---|
| 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 in physician's office and clinical laboratories. |
A multicenter clinical study was performed in four physician's offices/clinics (POL). The Genzyme Diagnostics Contrast" Strip hCG was provided to the sites. Each site also used the legally marketed Rapid hCG™ Urine/Serum Test. The Rapid hCG™ Urine/Serum Test is marketed for laboratory and professional use.
1
510(k) Notification Genzyme Diagnostics Contrast® Strip hCG October 15, 1996
Urine specimens were tested in four physician's offices using both Genzyme tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, post-menopausal women and assumed negatives.
Three physician's offices performed both Genzyme tests on serum specimens from female patients for either confirmation of pregnancy or non-pregnancy status prior to treatment (e.g. X-ray) for other disease states and post-menopausal women.
The results with both urine (209) and serum (177) samples demonstrate that the Genzyme Diagnostics Contrase Strip hCG has 100% agreement with the Rapid hCG™ Urine/Serum Test.
| Urine | Serum | ||||
|---|---|---|---|---|---|
| Strip hCG | Rapid hCG™ | Strip hCG | Rapid hCG™ | ||
| Positive | 75 | 75 | Positive | 72 | 72 |
| Negative | 134 | 134 | Negative | 105 | 105 |
At three POLs, eight individuals with various levels of training tested a blind reproducibility and sensitivity panel using the Genzyme Diagnostics Contrast® Strip hCG. The Genzyme Diagnostics Contrast® Strip hCG reproducibly detected hCG in urine at levels as low as 20 mIU/mL and as high as 1,000,000 mIU/mL and serum hCG at levels as low as 10 mIU/mL and as high as 1,000,000 mIU/mL.
These results establish that the Genzyme Diagnostics Contras® Strip hCG is substantially equivalent to the Rapid hCG™ Urine/Serum Test. The Genzyme Diagnostics Contras® Strip hCG Test can detect hCG concentrations of 20 mIU/mL in urine and 10 mIU/mL in serum.
The intended use of the Genzyme Diagnostics Contrast® Strip hCG is the early determination of pregnancy by the qualitative detection of human chorionic gonadotropin (hCG) in human serum or urine. Our intent is to market this product for laboratory and professional use.