(40 days)
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.
Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Genzyme Diagnostics Contrast® Strip hCG:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be >95%"). Instead, the study's primary objective was to demonstrate 100% agreement with an existing legally marketed device (the Rapid hCG™ Urine/Serum Test). The device also aimed to reproducibly detect hCG at specific concentration levels.
| Acceptance Criteria | Reported Device Performance (Contrast® Strip hCG) |
|---|---|
| 100% agreement with legally marketed device (Rapid hCG™ Urine/Serum Test) for urine samples | 100% agreement (75 Positive, 134 Negative) |
| 100% agreement with legally marketed device (Rapid hCG™ Urine/Serum Test) for serum samples | 100% agreement (72 Positive, 105 Negative) |
| Reproducible detection of hCG in urine | As low as 20 mIU/mL and as high as 1,000,000 mIU/mL |
| Reproducible detection of hCG in serum | As low as 10 mIU/mL and as high as 1,000,000 mIU/mL |
| Detect hCG concentrations in urine | 20 mIU/mL |
| Detect hCG concentrations in serum | 10 mIU/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Urine: 209 samples
- Serum: 177 samples
- Reproducibility/Sensitivity Panel: Not explicitly stated, but handled by eight individuals and included urine and serum samples with defined hCG levels.
- Data Provenance:
- Country of Origin: Not specified, but the study was conducted in "four physician's offices/clinics (POL)" and "three POLs," implying a local (likely US, given the 510(k) context) setting.
- Retrospective or Prospective: The study appears prospective, as specimens were tested in participating physician's offices from "female patients seeking confirmation of pregnancy, those who were confirmed pregnant, post-menopausal women and assumed negatives" and for "confirmation of pregnancy or non-pregnancy status prior to treatment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by comparing the Contrast® Strip hCG to the legally marketed and cleared Rapid hCG™ Urine/Serum Test. Therefore, the "experts" in this context are the original studies and validations performed for the Rapid hCG™ Urine/Serum Test, which is considered the reference standard here. The document does not specify the number or qualifications of experts involved in the original establishment of the Rapid hCG™ Urine/Serum Test's accuracy.
For the reproducibility and sensitivity panel, eight individuals with various levels of training tested the blind panel. Their specific qualifications (e.g., clinical laboratory scientists, nurses, physicians) are not detailed beyond "various levels of training."
4. Adjudication Method for the Test Set
There was no explicit "adjudication method" in the sense of multiple human readers independently assessing the results and then resolving discrepancies. The study's design was a direct comparison of the new device's results against those of the predicate device for each sample. The predicate device's result served as the "truth" for comparison. For the reproducibility panel, the expected hCG levels (known concentration) served as the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a traditional MRMC comparative effectiveness study was not explicitly described. The study focused on agreement with a predicate device and reproducible detection of known concentrations, not on measuring human reader improvement with or without AI assistance, as AI was not involved in this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a diagnostic test kit (an immunoassay strip), not an algorithm or AI. Its performance is inherent to the chemical reactions and visual interpretation, which is then performed by a human user without an AI component. The "standalone" performance is essentially what was evaluated through its agreement with the predicate device and its ability to detect known hCG concentrations.
7. The Type of Ground Truth Used
The primary ground truth for the clinical comparison was the results obtained from a legally marketed and predicate device (Rapid hCG™ Urine/Serum Test).
For the reproducibility and sensitivity claims, the ground truth was based on known concentrations of hCG in prepared panels.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a traditional diagnostic assay, not a machine learning model. There was no algorithm trained on data. The device's performance is determined by its inherent chemical and biological design.
9. How the Ground Truth for the Training Set Was Established
As there was no training set for a machine learning model, this question is not applicable. The ground truth for the study (test set) was established as described in section 7.
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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 Diagnostics1531 Industrial RoadSan Carlos, CA 94070 |
| Contact Person: | Delia R. Bethell, Ph.D.Director of Research and DevelopmentPhone: (415) 594-0513Fax: (415) 594-0571 |
| Equivalence Device: | Rapid hCG™ Urine/Serum Test510(k) Number: K952319Cleared June 20, 1995 |
| Device Description: | Rapid membrane based immunoassay for the qualitativedetection of hCG using mouse monoclonal anti-hCG andsheep anti-alpha hCG polyclonal antibodies. |
| Intended-Use: | The qualitative detection of human chorionic gonadotropin(hCG) in urine or serum for the early determination ofpregnancy 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.
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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.
§ 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.