(120 days)
The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
The subject device One Step Human Chorionic Gonadotropin (HCG) Test is identical to the previous cleared version of the device with the same name (K132085). The purpose of this special 510(k) submission is to expand shelf-life from 2 years to 3 years, the device itself has not changed.
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is a rapid sandwich immunoassay device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, as an aid in the early detection of pregnancy. The test devices are in three different formats: Strip,Cassette and Midstream . Three test formats use identical strips and each test strip in the device consists of:
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A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-β -HCG antibody specific to the beta subunit of hCG.
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A nitrocellulose membrane which is striped with the mouse monoclonal anti-α -HCG antibody in the test line (T line) and goat anti-mouse IgG polyclonal antibody in the control line (C line).
The Cassette format has the same performance specifications as the Test Strip format. The difference is that the urine sample is dispensed by dropper onto the sample well on the cassette.
The Midstream format has the same performance specifications as the Test Strip format. The difference is that the device is placed into the urine stream or dipped into the urine collection cup for 5 seconds.
This document describes the acceptance criteria and the study conducted to prove that the device meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a "Special 510(k) submission" where the primary purpose is to expand the shelf-life from 2 years to 3 years for the Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test devices. The device itself has not changed from its previously cleared version (K132085). Therefore, the acceptance criteria are focused on demonstrating that the device maintains its performance characteristics over the extended shelf-life.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life | Maintain performance for 3 Years. | Supported by stability study data (see below). The conclusion states the information supports substantial equivalence to the predicate. |
| Physical Testing | Maintain acceptable physical characteristics (eimplied, as part of quality assessment). | Included in the stability study. No specific metrics are given, but the overall conclusion indicates acceptability. |
| Positive Reference Conformity Rate | Maintain expected positive reactivity. | Included in the stability study. The overall conclusion indicates acceptability. |
| Negative Reference Conformity Rate | Maintain expected negative reactivity. | Included in the stability study. The overall conclusion indicates acceptability. |
| Sensitivity | Maintain sensitivity (detection limit) as per initial clearance (25mIU/mL). | Included in the stability study. The overall conclusion indicates acceptability. |
| Precision | Maintain precision (reproducibility of results). | Included in the stability study. The overall conclusion indicates acceptability. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The study described is a stability study designed to demonstrate the extended shelf-life of the device. It is not a clinical effectiveness study in the typical sense of testing patient samples against a ground truth for diagnostic accuracy.
- Sample Size: The study used 9 lots of HCG tests. The specific lot numbers are: 101180302, 101180303, 101180301C, 101180302C, 101180303C, 101180301M, 101180302M, 101180303M.
- Data Provenance: The study was conducted by the manufacturer, Co-Innovation Biotech Co., Ltd. in Guangzhou, China. It is a prospective study in the sense that the devices were placed under specific storage conditions for a defined duration (42 months) to assess stability over time. The "test set" here refers to the actual devices being tested, rather than a set of patient clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not directly applicable in the context of this stability study. The "ground truth" for a device's performance in a stability study typically refers to its performance at time zero or its established performance characteristics (e.g., sensitivity, positive/negative conformity based on internal reference panels) as measured by the manufacturer's validated quality control procedures. The study mentions "manufacturer inner Reference Panel," which would serve as the basis for evaluating positive and negative conformity, sensitivity, and precision. No external experts are mentioned for establishing this ground truth.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human interpretation of results or images is involved and consensus among experts is needed to establish a definitive diagnosis or ground truth. In this device stability study, the performance parameters (physical testing, conformity rates, sensitivity, precision) would be assessed against predefined specifications using internal reference panels and quantitative measurements, not through expert adjudication of individual test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable. The device is a qualitative immunochromatographic assay (a rapid test strip for HCG detection), not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study or assessment of AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is an in vitro diagnostic (IVD) test kit, not an algorithm or AI system. Its performance is inherent to the chemical and physical properties of the test strip/cassette/midstream, read visually by a human user.
7. The Type of Ground Truth Used
- For the stability study, the ground truth was established by the manufacturer's internal Reference Panel for assessing positive reference conformity rate, negative reference conformity rate, sensitivity, and precision. This panel represents known concentrations or characteristics used to validate the device's performance over time. The primary clinical cut-off for the device itself is 25mIU/mL of hCG in urine, traceable to WHO 3rd IS.
8. The Sample Size for the Training Set
- This question is not applicable to this type of device and study. "Training set" refers to data used to train machine learning models. This is a traditional IVD device, not an AI/ML product. The development of the device's components and design would typically involve extensive R&D and validation, but not in the context of a "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the reasons stated in point 8.
§ 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.