Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream by Co-Innovation Biotech Co.,Ltd.

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.

Device Description

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:

A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-β -HCG antibody specific to the beta subunit of hCG.
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.

AI/ML Overview

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.

Summary

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April 5, 2022

Co-Innovation Biotech Co., Ltd. Hong Feng Product Manager No. 9 Baihe 3 Street, Economic And Technological Development East Zone Guangzhou, Guangdong 510507 China

Re: K213808

Trade/Device Name: Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette .Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: December 6, 2021 Received: December 6, 2021

Dear Hong Feng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213808

Device Name

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 - 510(k) Summary

Date of Summary Preparation: 31/03/2022

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No. 9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

2. Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No. 9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda(@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Recommended classification regulation: 21 CFR 862.1155 Device class: Class II Panel: Clinical Chemistry (75) Product code: LCX Common Name:Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Proprietary names:

4. The Predicate Devices

One Step Human Chorionic Gonadotropin (HCG) Test K132085

5. Device Description

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is a rapid sandwich

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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:

A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-β -HCG antibody specific to the beta subunit of hCG.
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.

6. Intended Use of Device

7. Comparison to Predicate Devices:

A summary comparison of features of the Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test and the predicate devices is provided in the following Table:

Item	Subject device	Predicate (K132085)	Remark
Indication for use	Qualitative detection ofhuman chorionicgonadotropin (“HCG”)in urine	Qualitative detection ofhuman chorionicgonadotropin (“HCG”)in urine	Same
Intended Users	Over the Counter (OTC)	Over the Counter(OTC)	Same
Component	NitrocelluloseMembrane,	NitrocelluloseMembrane,	Same

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	Gold Spray Fiber,Glass fiber	Gold Spray Fiber,Glass fiber
Specimen	Urine	Urine	Same
Clinical cut-off	25mIU/mL	25mIU/mL	Same
Read time	5 minutes	5 minutes	Same
Storage	4 ~ 30 °C	4 ~ 30 °C	Same
Test Principle	Colloidal GoldImmunoassay	Colloidal GoldImmunoassay	Same
Traceability	WHO 3rd IS	WHO 3rd IS	Same
Format	Strip,cassette,midstream	Strip,cassette,midstream	Same
Antibodies	Monoclonalanti-ß-HCG antibody ,monoclonal anti-α-HCGantibody, goat antimouse IgG polyclonalantibody	Monoclonalanti-ß-HCG antibody ,monoclonalanti-α-HCG antibody,goat anti mouse IgGpolyclonal antibody	Same
Shelf-life	3 Years	2 Years	Differences

Remark:

1、The subject devices have all features of the predicate device except the Shelf-life. The subject device have performed the Stability Study.This differences do not affect the performance characteristics of the subject devices.

8. Standard/Guidance Document Referenced (if applicable):

Guidance for Over-the Counter (OTC) Human Chorionic Gonadotropin (HCG) 510(k)s

9. Test principles:

The assay tests the human chorionic gonadotropin (HCG) qualitatively in the urine specimen, using the double antibody sandwich method. Each test device contains mouse monoclonal anti-ß-HCG antibody colloidal gold conjugate pre-dried on a pad.Mouse monoclonal anti-a:-HCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a Nitrocellulose membrane. During the test procedures, the intact hCG in the urine specimen reacts with the dye conjugate (mouse anti-ß-HCG antibody-colloidal gold conjugate specific to the beta subunit of hCG) and form Ag-Abp-Au complexes. Because of capillary and chromatographic effects of the Nitrocellulose membrane, the complexes migrate along the membrane to the a-HCG antibody line (T), form Abo-Ag-Abβ-Au complexes and remain captured in the T line. As a result a red colored band develops in T and the result is positive. If there is no HCG in the urine, there is no red band in the Test zone, indicating negative result. No matter if there's HCG in the urine specimen, when the complexes migrate along the Control zone, a red band must be developed in the C zone.

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10.Antibody Information

Antibody	The biological source	The location	Specific target antigen
Monoclonalanti-β-HCG antibody	Mouse	Conjugate pad	Specific to the betasubunit of hCG
Monoclonalanti-α-HCG antibody	Mouse	Nitrocellulosemembrane	Specific to the alphasubunit of hCG
goat anti mouse IgGpolyclonal antibody	Goat	Nitrocellulosemembrane

11. Stability Study Data:

11.1 The methods of the testing:

Take 9 lots HCG tests, with the lot numbers 101180302,101180303, 101180301C, 101180302C,101180303C101180301M,101180302M,101180303M, place them at 4℃ and 30℃ for 42 months, then make the study of the physical testing, positive reference conformity rate, negative reference conformity rate, sensitivity, and precision based on the manufacturer inner Reference Panel.

11.2 Conclusion

The information provided supports that the devices are substantially equivalent to the predicate.

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Regulation Number and Section

§ 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.