(120 days)
Not Found
No
The device description details a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and visual interpretation, not AI/ML. The submission is for a shelf-life extension, not a change in technology.
No
The device is an in vitro diagnostic (IVD) test designed to detect pregnancy by measuring hCG levels in urine. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic visual qualitative immunochromatographic assay."
No
The device description clearly outlines physical components like a conjugate pad, nitrocellulose membrane, and different formats (Strip, Cassette, Midstream) that interact directly with a urine sample. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay..."
and similar language is used for the Cassette and Midstream formats.
The "Device Description" also refers to the device as 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." This description aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (OTC) use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability Study Data:
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.
Conclusion: The information provided supports that the devices are substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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:
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
4. The Predicate Devices
One Step Human Chorionic Gonadotropin (HCG) Test K132085
5. 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
4
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.
6. Intended Use of Device
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.
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 of | ||
| human chorionic | |||
| gonadotropin (“HCG”) | |||
| in urine | Qualitative detection of | ||
| human chorionic | |||
| gonadotropin (“HCG”) | |||
| in urine | Same | ||
| Intended Users | Over the Counter (OTC) | Over the Counter | |
| (OTC) | Same | ||
| Component | Nitrocellulose | ||
| Membrane, | Nitrocellulose | ||
| Membrane, | Same |
5
| | 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 Gold
Immunoassay | Colloidal Gold
Immunoassay | Same |
| Traceability | WHO 3rd IS | WHO 3rd IS | Same |
| Format | Strip,cassette,midstream | Strip,cassette,midstream | Same |
| Antibodies | Monoclonal
anti-ß-HCG antibody ,
monoclonal anti-α-HCG
antibody, goat anti
mouse IgG polyclonal
antibody | Monoclonal
anti-ß-HCG antibody ,
monoclonal
anti-α-HCG antibody,
goat anti mouse IgG
polyclonal 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.
6
10.Antibody Information
| Antibody | The biological source | The location | Specific target antigen |
|---|---|---|---|
| Monoclonal | |||
| anti-β-HCG antibody | Mouse | Conjugate pad | Specific to the beta |
| subunit of hCG | |||
| Monoclonal | |||
| anti-α-HCG antibody | Mouse | Nitrocellulose | |
| membrane | Specific to the alpha | ||
| subunit of hCG | |||
| goat anti mouse IgG | |||
| polyclonal antibody | Goat | Nitrocellulose | |
| membrane |
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.
--- End of this section ---