(62 days)
Accunate Home Pregnancy Test is an over-the-counter (OTC) one-step qualitative test for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
ACCUNATE™ONE-STEP, ACCUNATE™ONE-STEP CASSETTE and ACCUNATE-CHOICE™ are rapid lateral flow colloidal gold immunological tests for the qualitative determination of human chorionic gonadotropin (hCG) in urine or in urine and serum for the early detection of pregnancy.
Here's a breakdown of the acceptance criteria and study information for the ACCUNATE series of pregnancy tests, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" as a separate, defined section with numerical targets. Instead, the studies aim to demonstrate "substantial equivalence" of the new devices to existing predicate devices. The performance metrics are relative to these predicates and directly inform the claim of equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Agreement with Predicate (ACCUNATE™ONE-STEP & ACCUNATE™ONE-STEP CASSETTE vs. Abbott Test Pack Plus™) | 100% agreement with predicate | 100% agreement (63 positives, 68 negatives) | Demonstrates comparable qualitative detection of hCG in urine. |
| Agreement with Predicate (ACCUNATE-CHOICE™ vs. Quidel's Quick-Vue®) | 100% agreement with predicate | 100% agreement (59 positives, 60 negatives) | Demonstrates comparable qualitative detection of hCG in urine or serum. |
| Sensitivity (Detection Limit) | 25 mIU/ml or better (implied by predicate devices' capabilities) | 25 mIU/ml | Demonstrated by detecting hCG at 25 mIU/ml and above, but not at 5 mIU/ml. |
| Home User vs. Professional User Agreement (ACCUNATE™ HOME PREGNANCY TEST vs. ACCUNATE™ ONE-STEP CASSETTE) | High agreement, demonstrating user-friendliness and reliable results in a home setting (no explicit percentage given, but 98% is achieved). | 98% agreement (47 home positives vs. 46 lab, 59 home negatives vs. 61 lab, 1 home invalid vs. 0 lab) | This study assesses the usability and accuracy of the home test when used by laypersons compared to trained professionals. |
2. Sample Size Used for the Test Set and Data Provenance
- ACCUNATE™ONE-STEP & ACCUNATE™ONE-STEP CASSETTE:
- Sample Size: 131 urine specimens.
- Data Provenance: Prospective. Specimens were from "patients seeking confirmation of pregnancy" and tested simultaneously with the devices and predicate. The study was conducted at "three clinic sites," implying a likely domestic (USA) origin given the context of a US regulatory submission.
- ACCUNATE-CHOICE™:
- Sample Size: 119 serum specimens.
- Data Provenance: Prospective. Specimens from "normal male and non pregnant females" were tested simultaneously. The study details are similar to the above, suggesting a domestic (USA) origin.
- Sensitivity Testing:
- Sample Size: 20 urine specimens and 20 serum specimens for each hCG concentration (0, 5, 25, 50, 100 mIU/ml). This means a total of 100 urine samples and 100 serum samples were tested across the concentrations.
- Data Provenance: Controlled laboratory spike study. No geographic origin specified, but likely conducted internally or at a contract lab.
- Home User Study (ACCUNATE™ HOME PREGNANCY TEST):
- Sample Size: 107 participants/samples.
- Data Provenance: Prospective. Conducted at "three clinic sites," with participants being home users testing their own urine. Likely domestic (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The studies rely on the performance of predicate devices (Abbott Test Pack Plus™ and Quidel's Quick-Vue®) as the de facto "ground truth" for comparative effectiveness. These devices are established, legally marketed pregnancy tests.
For the home user study, the "ground truth" was established by laboratory professionals using the ACCUNATE™ ONE-STEP CASSETTE. The qualifications of these professionals are not explicitly stated (e.g., "radiologist with 10 years of experience"), but it is implied they are trained and experienced in performing such clinical laboratory tests. There's no mention of a specific number of experts beyond "the laboratory."
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparisons are based on direct agreement with the predicate devices' results or the laboratory results in the home user study. Discrepancies, especially in the home user study, are noted (e.g., one home invalid result not found by the lab), but no formal adjudication process for such discrepancies is detailed in the summary. For the comparative studies, 100% agreement means no discrepancies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No formal MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is measured. These studies are focused on the standalone performance of the devices and their agreement with predicate devices or a professional laboratory reference.
6. Standalone (Algorithm Only) Performance
Yes, standalone performance was done. The entire set of studies focuses on the device's performance as a standalone test, without human interpretation influencing the primary result (though humans obviously perform the test and read the result). The "100% agreement" and "25 mIU/ml sensitivity" directly reflect the standalone performance of the ACCUNATE devices.
7. Type of Ground Truth Used
- Comparative Studies (with Abbott Test Pack Plus™ and Quidel's Quick-Vue®): Predicate device results. This is a common approach for demonstrating substantial equivalence for new diagnostic devices. The assumption is that the predicate device's results are accurate and serve as the clinical reference.
- Sensitivity Study: Laboratory-prepared spiked samples with known concentrations of hCG. This is a controlled, objective ground truth for measuring the detection limit.
- Home User Study: Laboratory professional results using a comparable ACCUNATE™ device (ACCUNATE™ ONE-STEP CASSETTE). This serves as the expert reference for evaluating home user accuracy.
8. Sample Size for the Training Set
The document does not mention any "training set." These devices (lateral flow immunoassays) are not AI/algorithm-based devices that typically require training data. Their performance is inherent to their chemical and physical design.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable.
§ 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.