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

K213808 · Co-Innovation Biotech Co., Ltd. · LCX · Apr 5, 2022 · Clinical Chemistry

Device Facts

• Record ID: 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
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 5, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

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.

Device Story

Rapid sandwich immunoassay for qualitative hCG detection in urine; aids early pregnancy detection. Three formats: strip, cassette, midstream. Input: urine sample. Principle: immunochromatographic assay using colloidal gold-conjugated mouse monoclonal anti-beta-HCG antibodies on a conjugate pad and immobilized mouse monoclonal anti-alpha-HCG antibodies (test line) and goat anti-mouse IgG (control line) on a nitrocellulose membrane. Operation: sample migrates via capillary action; hCG binds to gold-conjugate, then captured at test line forming visible red band. Control line confirms test validity. Used in home/OTC setting by lay users. Output: visual qualitative result (presence/absence of red bands). Benefits: rapid, convenient pregnancy screening.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification testing confirming the impact of the shelf-life extension.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout. Form factors: strip, cassette, midstream. Shelf life: 3 years. Fundamental scientific technology identical to predicate K132085.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Intended for over-the-counter (OTC) use by the general population.

Regulatory Classification

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. 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.

Predicate Devices

• One Step Human Chorionic Gonadotropin (HCG) Test (K132085)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K213808

B Applicant

Co-Innovation Biotech Co., Ltd.

C Proprietary and Established 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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCX | Class II | 21 CFR 862.1155 - Human Chorionic Gonadotropin (HCG) Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream, k132085.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Increasing the shelf life claim from 2 to 3 years.

- Change in names from Co-Innovation One Step HCG Test Strip, Co-Innovation One Step HCG Test Cassette, and Co-Innovation One Step HCG Test Midstream to Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, and Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream, respectively.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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