(343 days)
The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.
The test is intended for home use.
The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip.
The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women.
The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.
The provided document describes the performance and testing of the "Clearblue® Early Pregnancy Test," a qualitative immunoassay for detecting human chorionic gonadotropin (hCG) in urine. This document pertains to its 510(k) premarket notification (K213379) to the FDA.
Here's a breakdown of the acceptance criteria and study proving device performance, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a table format with pass/fail remarks. However, the performance characteristics sections imply certain criteria are met for the device to be considered substantially equivalent. Based on the studies, here is a summary of the implicit criteria and reported performance:
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Clearblue® Early Pregnancy Test) |
|---|---|
| Accuracy (Lay User Study vs. Clinical Status) | 100% agreement (PPV, NPV, Sensitivity, Specificity) |
| - Pregnant Cohort | 100% detection (152/152 pregnant samples correctly identified) |
| - Not Pregnant Cohort | 100% negative results (143/143 not pregnant samples correctly identified) |
| Accuracy (Lay User vs. Technician) | 100% agreement between lay user and technician results |
| Precision/Reproducibility | Consistent results across technicians, batches, and days, especially at 10 mIU/ml hCG and above (100% pregnant results). |
| - 10 mIU/ml hCG | 100% Pregnant results |
| - 15 mIU/ml hCG | 100% Pregnant results |
| - 20 mIU/ml hCG | 100% Pregnant results |
| - * |
§ 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.