(130 days)
Not Found
No
The device description and performance studies describe a standard immunochromatographic assay with visual interpretation, not involving any computational analysis or pattern recognition typically associated with AI/ML.
No
This device is an in vitro diagnostic (IVD) test designed for the early detection of pregnancy by determining hCG levels in urine. It is used to diagnose a condition, not to treat or therapeutically manage it.
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 and nitrocellulose membrane, indicating it is a physical test strip/cassette/midstream, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The Co-Innovation One Step 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 it as an "in vitro diagnostic visual qualitative immunochromatographic assay".
These statements clearly indicate that the device is intended for use outside of the body to examine specimens (urine in this case) to provide information for the diagnosis of a condition (pregnancy).
N/A
Intended Use / Indications for Use
The Co-Innovation One Step 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 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 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
LCX
Device Description
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-B-HCG antibody specific to the beta subunit of hCG.
-
A nitrocellulose membrane which is striped with the mouse monoclonal anti-a-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
Ages were from 18 to 45 years.
Intended User / Care Setting
Over-the-counter (OTC) use. The study was performed at 3 different point-of-care sites in Guangzhou, Shanghai and Wuhan.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: 30 clinical samples from normal, nonpregnant females spiked with HCG at different concentrations (0, 12.5, 18.75, 25, 50, 100 mIU/ml). The study was conducted for 3 runs/day over 10 days by three hospital laboratories using 3 batches of Co-Innovation One Step HCG Test for each of the three formats. The midstream format was tested using both simulated midstream and dip methods. All concentrations were determined by immunoassay of ELISA. The results showed good precision across all batches and formats, with no false positives at 0, 12.5, or 18.75 mIU/ml, and consistent positive results at 25, 50, and 100 mIU/ml.
Sensitivity study: The sensitivity of Co-Innovation One Step HCG Test is 25mIU/ml, derived from the precision data.
Specificity study: 500mIU/ml LH, 1000mIU/ml FSH, and 1000uIU/ml TSH were spiked separately into 60 urine specimens containing HCG at 0 mIU/ml and 25mIU/ml. 3 lots of samples were tested. The results showed no cross-reaction with LH, FSH, or TSH at the tested concentrations.
Study on interfering substances: Exogenous compounds (Acetaminophen, Aspirin, Ascorbic acid, Atropine, Caffeine, Glucose, Hemoglobin, Tetracycline, Ampicillin, Albumin, Bilirubin) at specified concentrations, and HCG ß-core fragment at high concentrations (125,000 to 1,000,000 pmol/mL) were spiked into normal, nonpregnant female urine specimens containing 0 and 25 mIU/ml HCG. 3 batches of each format were tested. No interferences were observed from these substances or the HCG ß-core fragment.
PH interference: The pH of aliquot negative urine pools was adjusted from 3 to 9 in 1 pH unit increments and spiked with HCG at 25mlU/ml and 0mlU/ml. 3 batches of Co-Innovation One Step HCG Test were tested repeatedly. The results demonstrate that varying pH ranges do not interfere with the performance of the test.
Specific gravity interference: Purified water and specimens with HCG 25mlUml were formulated into solutions with specific gravity at 1.01, 1.02, 1.03, and 1.04. 3 lots of Co-Innovation One Step HCG Test were tested. The data showed no interference when specific gravity was between 1.01-1.04.
Urinary system diseases interference: Urine specimens strong positive for white blood cells, urine occult blood, uric acid, and urine ketone were collected and prepared at HCG 0mlU/ml and 25mlU/ml. 3 lots of samples were tested repeatedly. The data showed no interference from these substances.
HOOK effect study: HCG free specimens were spiked with HCG at concentrations ranging from 62,500mIU/ml to 1,000,000mIU/ml. Three lots of tests were tested. The results show that the One Step HCG Test can get a positive result across this range, though the T-line becomes lighter at concentrations above 125,000mIU/ml.
Professional method Comparison: Urine samples were collected from 353 women at a hospital laboratory. Approximately half were early pregnancy (less than 5 weeks since last menstrual period). Samples were randomly collected, and ages were 18 to 45 years. Each specimen was blind coded and randomized. Tests were performed by laboratory professionals at two laboratories (Professional A and Professional B) using both the candidate device and the predicate device. The agreement of Co-Innovation One Step HCG Test with the predicate device was 100%.
Lay user method Comparison: Urine samples collected from the same 353 women as the professional comparison were tested by lay users. 80 lay users used the test strip, 113 used the test cassette, and 160 used the midstream method (actual and dip). Lay users followed the English package insert. The lay user results were compared to those of laboratory professionals testing the same samples with the candidate devices. The results showed 100% agreement between lay users and professionals for all formats.
Performance tested by OTC user: HCG free specimens spiked with HCG at 18.75mlU/ml and 31.25mlU/ml (determined by ELISA) were tested. 240 aliquots (120 of each concentration) were blindly labeled and randomized. 240 female subjects (ages 18 to 45, various education backgrounds, no prior experience) participated in the study at 3 point-of-care sites. Each subject performed one test on one format or sample application method for the midstream test, guided by the English package insert. Masked spiked urine samples were also tested by professional laboratory personnel at the manufacturer site. The results demonstrate that Co-Innovation One Step HCG Test can be used by untrained operators and yield correct results. For the strip, 29 positives were correctly identified, and 30 negatives. For the cassette, 30 positives and 30 negatives were correctly identified. For midstream using the dip method, 30 positives and 30 negatives were correctly identified. For midstream using the simulated midstream method, 30 positives were correctly identified (with 1 false positive) and 29 negatives.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25mIU/ml.
For precision study, at 25mIU/ml, 50mIU/ml, and 100mIU/ml HCG, all samples (30 per concentration per lot for 3 lots) showed positive results. At 0, 12.5, and 18.75mIU/ml, all samples (30 per concentration per lot for 3 lots) showed negative results.
Specificity: No cross-reaction with LH (500mIU/ml), FSH (1000mIU/ml), TSH (1000uIU/ml). No interference from various exogenous compounds, HCG ß-core fragment, varying pH ranges, specific gravity between 1.01-1.04, or substances related to urinary system diseases.
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
510(k) Summary
Date of Summary Preparation: 11/11/2013
1. Submitter's Identifications
Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285
2. Name of the Device
Recommended classification regulation: 21 CFR 862.1155
NOV 1 2 2013
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 HCG Test Strip
Co-Innovation One Step HCG Test Cassette
Co-Innovation One Step HCG Test Midstream
3. The Predicate Devices
One Step HCG Urine Pregnancy Test
4. Device Description
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-B-HCG antibody specific to the beta subunit of hCG.
-
A nitrocellulose membrane which is striped with the mouse monoclonal anti-a-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
1
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.
5. Intended Use of Device
The Co-Innovation One Step 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 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 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 .
6. 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 | Device | Predicate (K071930) |
|---|---|---|
| Indication for use | Qualitative detection of human | |
| chorionic gonadotropin ("HCG") in | ||
| urine | Same | |
| Intended Users | Over the Counter (OTC) | Over the Counter (OTC) |
| Use and Prescription Use | ||
| Specimen | Urine | Same |
| Clinical cut-off | 25mIU/mL | Same |
| Read time | 5 minutes | Same |
| Storage | 4 ~ 30 °C | Same |
| Test Principle | Colloidal Gold Immunoassay | Same |
| Traceability | WHO 3rd IS | Same |
| Format | Strip,cassette,midstream | Same |
| Antibodies | Monoclonal anti-β-HCG antibody, | |
| monoclonal anti-α-HCG antibody, | ||
| goat anti mouse IgG polyclonal | Differ |
2
The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is similar to the predicate device with intended use,clinical cut-off,read time,test format,etc.
Specific antibodies differ.
7. Standard/Guidance Document Referenced (if applicable):
Guidance for Over-the Counter (OTC) Human Chorionic Gonadotropin (HCG) 510(k)s ISO 14971:2007 Medical devices - Application of risk management to medical devices
8. 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-B-HCG antibody colloidal gold conjugate pre-dried on a pad.Mouse monoclonal anti-ar-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-AbB-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 Aba-Ag-AbB-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.
9. 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 |
10. Performance Data:
Precision
30 clinical samples from normal,nonpregnant females spiked with the HCG(traceable to WHO 3rd IS) at different concentration containing 0mlU/ml, 18.75mlU/ml, 25mlU/ml, 25mlU/ml, 50mlU/ml, 100mlU/ml (All the concentration was determined by immunoassay of ELISA).The controls were blind coded.Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted 3 runs /day and lasted 10 days and was
3
conducted by three hospital laboratories . There are 3 batches Co-Innovation One Step HCG Test of three formats and each laboratory should conduct one batch separately. The midstream format were performed with both of these midstream test sample application methods (simulated midstream and dip). The result was recorded as the following:
| HCG Concentration | LOT1 | LOT2 | LOT3 | |||
|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |
| 0mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results of precision (strip )
The results of precision (cassette)
| HCG Concentration | LOT1 | LOT2 | LOT3 | |||
|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |
| 0mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results of precision (midstream, using the dip method )
| HCG Concentration | LOT1 | LOT2 | LOT3 | |||
|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |
| 0mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 100mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
The results of precision (midstream,using the simulated midstream method )
| HCG Concentration | LOT1 | LOT2 | LOT3 | |||
|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |
| 0mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 12.5mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 18.75mlU/ml | 0 | 30 | 0 | 30 | 0 | 30 |
| 25mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
| 50mlU/ml | 30 | 0 | 30 | 0 | 30 | 0 |
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| 1
1 | | A . A . A | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
( | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------- | -- | ----------- | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
The results show that the precision of Co-Innovation One Step HCG Test in three batches of different formats are good.
Sensitivity study
According to the results of precision data above, the sensitivity of Co-Innovation One Step HCG Test is 25mlU/ml.
Specificity study
500mlU/ml LH(traceable to WHO 2ª01S)、1000mlU/ml FSH(traceable to WHO 2nd JRP) and 1000ulU/ml TSH(traceable to WHO 2mlRP) were spiked separately into the 60 urine specimen containing HCG at 0 mIU/ml and 25mlU/ml, respectively. 3 lots of samples were tested. According to the results, there's no cross reaction with LH at 500mIU/ml , FSH at 1000mlU/ml and TSH at 1000uIU/ml.
Study on the interfering substances
To evaluate the potential for interference by certain exogenous compounds, each compound was prepared by diluting stock interferent material to the desired concentration. Normal, nonpregnant females urine specimens containing 0 and 25 mIU/ml HCG were spiked with the interferents to obtain the desired test concentration. 3 batches of each format were tested. The results show that no interferences were observed from exogenous compounds at the following concentrations for both negative and positive HCG urine samples.
| Interfering substances | Substances concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Aspirin | 20mg/dL |
| Ascorbic acid | 20mg/dL |
| Atropine | 20mg/dL |
| Caffeine | 20mg/dL |
| Glucose | 2000mg/dL |
| Hemoglobin | 500mg/dL |
| Tetracycline | 20mg/dL |
| Ampicillin | 20mg/dL |
| Albumin | 2000mg/dL |
| Bilirubin | 2mg/dL |
To evaluated the effects of the HCG ß-core fragment ,normal,nonpregnant females urine specimens containing 0 and 25 mlU/ml HCG were spiked with the HCGB-core fragment (traceable to WHO reference reagent 99/708) at the concentration of 125,000,250,000, 500,000 and 1,000,000 pmol/mL.3 batches of each format were tested. The above data show that there's no interference in the test result when the HCGB-core fragment at the highest levels at which it is likely to be found in patient samples.
5
PH interference:
The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with HCG at 25mlU/ml and 0mlU/ml and 3 batches of Co-Innovation One Step HCG Test were tested repeatedly. The result demonstrate that varying ranged of PH do not interfere with the performance of the test.
Specific gravity interference:
Purified water and specimen with HCG 25mlUml were formulated into the solution with specific gravity at 1.01,1.02.1.03,1.04 separately. 3 lots of Co-Innovation One Step HCG Test were tested. The data show that there's no interference in the test result when the specific gravity is between 1.01-1.04.
Urinary system diseases interference:
Urine specimen which the items of white blood cells, urine occult blood, uric acid and urine ketone was/were strong positive were collected and for preparing the solution at HCG 0mlU/ml and 25mlU/ml. 3 lots of samples were tested repeatedly. The data show that the substance of leukocyte, erythrocyte, Urine occult blood, Urine acid or Ketone in the urine had no interference on the test result.
HOOK effect study
HCG free specimens spiked with the HCG at different concentration containing 62500mlU/m1. 125000mlU/ml, 250000mlU/ml, 500000mlU/ml, 1000000mlU/ml. Three lots of tests were tested. The results show that One Step HCG Test can get the positive result when the HCG concentration is range from 62,500 to 1,000,000m1U/ml, while the T line get to light as the concentration above 125000mlU/ml.
Professional method Comparison :
Urine samples were collected from 353 women at hospital laboratory to test for pregnancy. Approximately half of the women were pregnant in the early stage of less than 5 weeks (that meats less than 5 weeks since last menstrual period). Samples were randomly collected at various times throughout the day. Ages were from 18 to 45 years.Each specimen was blind coded.Separate sets of the blind coded were assigned.Samples were also randomized prior to tests performed by laboratory professionals were conducted at two laboratories (namely Professional A and Professional B). Each person tested the candidate device and the predicate device at the same time, but not sequentially. The data show that the agreement of Co-Innovation One Step HCG Test with the predicate device was 100%.
The results of professional method comparison (strip )
| Candidate device | Predicate device
Professional | | |
|------------------|----------------------------------|----------|----|
| | Positive | Negative | |
| Professional A | Positive | 38 | 0 |
| | Negative | 0 | 42 |
5-6
6
| Positive | |||
|---|---|---|---|
| Professional B | Positive | 38 | 0 |
| Negative | 0 | 42 |
The results of professional method comparison (cassette)
| Candidate device | | | Predicate device
Professional | | |
|------------------|----------|----------|----------------------------------|--|--|
| | | Positive | Negative | | |
| Professional A | Positive | 39 | 0 | | |
| | Negative | 0 | 74 | | |
| Professional B | Positive | ਤੇ ਹੋ | 0 | | |
| | Negative | 0 | 74 | | |
The results of professional method comparison (midstream, using dip method)
| Candidate device | Predicate device
Professional | | |
|------------------|----------------------------------|----------|----|
| | Positive | Negative | |
| Professional A | Positive | 37 | 0 |
| | Negative | 0 | 43 |
| Professional B | Positive | 37 | 0 |
| | Negative | 0 | 43 |
The results of professional method comparison (midstream.using the simulated midstream method)
| Candidate device | Predicate device
Professional | | |
|------------------|----------------------------------|----------|----|
| | Positive | Negative | |
| Professional A | Positive | 41 | 0 |
| | Negative | 0 | 39 |
| Professional B | Positive | 41 | 0 |
| | Negative | 0 | 39 |
The lay user method Comparison :
Urine samples were collected from 353 women at hospital laboratory to test for pregnancy. Approximately half of the women were pregnant in the early stage of less than 5 weeks (that meats less than 5 weeks since last menstrual period). Samples were randomly collected at various times throughout the day. Ages were from 18 to 45 years. These 353 layer users test their own urine using the English package insert as guide to perform the test.This included 80 layer users using test strip, 113 using test cassette, 160 using actual midstream method and the dip method
7
respectively for test midstream. They were asked to fill out an English questionnaire after finishing the test and collected samples for tests by laboratory professionals using the candidate devices. Each specimen was blind coded.Separate sets of the blind coded were assigned.Samples were also randomized prior to testing.The tests performed by laboratory professionals were conducted at a laboratory .
The results of the lay user method comparison (strip )
| Candidate device | | Candidate device
Professional | |
|------------------|----------|----------------------------------|----------|
| | | Positive | Negative |
| Layer users | Positive | 38 | 0 |
| | Negative | 0 | 42 |
The results of the lay user method comparison (cassette)
| Candidate device | | Candidate device
Professional | |
|------------------|----------|----------------------------------|----------|
| | | Positive | Negative |
| Layer users | Positive | 39 | 0 |
| | Negative | 0 | 74 |
The results of the lay user method comparison (midstream,using dip method)
| Candidate device | | Candidate device
Professional | |
|------------------|----------|----------------------------------|----------|
| Layer users | | Positive | Negative |
| | Positive | 37 | 0 |
| | Negative | 0 | 43 |
The results of the lay user method comparison (midstream,using the actual midstream method)
| Candidate device | Candidate device Professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Layer users | Positive | 41 | 0 |
| Layer users | Negative | 0 | 39 |
The performance tested by OTC user:
To evaluate its suitability to be used by the home use consumers (lay persons), spiked urine samples were tested by the lay persons and the results were compared with professional laboratory
8
results. The study was performed at 3 different point-of-care sites in Guangzhou, Shanghai and Wuhan.HCG free specimens spiked with the HCG (material traceable to WHO 3rd 1S) at 18.75mlU/ml and 31.25mlU/ml. Both the concentration was determined by immunoassay of ELISA. Each concentration urine specimens were divided into 120 individual containers for a total of 240 aliguots. All aliquots were blindly labeled by a nonparticipant. Samples were also randomized prior to testing.240 female subjects with various education backgrounds and the ages from 18 to 45 participated in the lay user study. All of the subjects had no the experience of using the test before and were the untrained operators. Each subject conducted I test on one test format or one sample application method for the "midstream" using the English package insert as guide . Masked spiked urine were tested by professional laboratory personnel at the manufacturer site. The results show that Co-Innovation One Step HCG Test can be used by the untrained operator and get the correct results.
| Formats | Masked spiked sample | | Masked spiked sample
Professional users | |
|-------------------------------------------------------|----------------------|----------------|--------------------------------------------|----------------|
| | | | +(31.25mlU/ml) | -(18.75mlU/ml) |
| Strip | Layer users | +(31.25mlU/ml) | 29 | 0 |
| | | -(18.75mlU/ml) | 1 | 30 |
| Cassette | Layer users | +(31.25mlU/ml) | 30 | 0 |
| | | -(18.75mlU/ml) | 0 | 30 |
| Midstream,using dip
method | Layer users | +(31.25mlU/ml) | 30 | 0 |
| | | -(18.75mlU/ml) | 0 | 30 |
| Midstream, using the
simulated midstream
method | Layer users | +(31.25mlU/ml) | 30 | 1 |
| | | -(18.75mlU/ml) | 0 | 29 |
Results of performance tested by OTC user
11. Conclusion:
The results of evaluated studies demonstrate the substantial equivalency between Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test and the Predicate device. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supports substantial equivalence to the predicate device.
-- End of this section ---
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure. The symbol is likely associated with the Department of Health and Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2013
CO-INNOVATION BIOTECH CO., LTD. HONG FENG PRODUCT MANAGER NO. 13 YANYUAN ROAD, TIANHE DISTRICT GUANGZHOU, GUANGDONG, CHINA 510507
Re: K132085
Trade/Device Name: Co-Innovation One Step HCG Test Strip Co-Innovation One Step HCG Test Cassette Co-Innovation One Step HCG Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX
Dated: September 29, 2013 Received: October 2, 2013
Dear Ms. 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 10 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. 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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
10
Page 2-Ms. Feng
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K132085
Device Name: Co-Innovation One Step HCG Test Strip Co-Innovation One Step HCG Test Cassette Co-Innovation One Step HCG Test Midstream
Indications for Use:
The Co-Innovation One Step 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 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 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 .
AND/OR
Prescription Use __
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
×
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132085