(130 days)
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.
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.
Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the studies conducted to demonstrate the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful outcomes presented in the study results, particularly for precision and sensitivity, as no explicit numerical acceptance targets are stated (e.g., "sensitivity must be >99%"). However, the performance data clearly demonstrates that the device meets the implicit requirement for accurate qualitative detection of HCG at the clinical cut-off of 25mIU/mL.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Precision: Consistent positive results at/above 25mIU/mL and negative results below 25mIU/mL. | Precision (Strip, Cassette, Midstream - all methods): - 0mIU/mL, 12.5mIU/mL, 18.75mIU/mL: 100% negative (30/30 for each LOT and concentration). - 25mIU/mL, 50mIU/mL, 100mIU/mL: 100% positive (30/30 for each LOT and concentration). |
| Sensitivity: Detect HCG at the clinical cut-off of 25mIU/mL. | Sensitivity: 25mIU/mL (derived from precision study, showing 100% detection at this concentration). |
| Specificity: No cross-reactivity with common related hormones. | Specificity: No cross-reaction observed with LH at 500mIU/mL, FSH at 1000mIU/mL, and TSH at 1000uIU/ml in urine specimens containing 0 mIU/ml and 25mIU/ml HCG. |
| Interference: No interference from common exogenous compounds. | Interference: No interferences observed from Acetaminophen, Aspirin, Ascorbic acid, Atropine, Caffeine (all at 20mg/dL), Glucose (2000mg/dL), Hemoglobin (500mg/dL), Tetracycline, Ampicillin (all at 20mg/dL), Albumin (2000mg/dL), Bilirubin (2mg/dL) for both negative and positive HCG samples. |
| HCG ß-core fragment interference: No interference from high levels of HCG ß-core fragment. | HCG ß-core fragment interference: No interference was observed when spiked at 125,000, 250,000, 500,000, and 1,000,000 pmol/mL in urine samples containing 0 and 25 mlU/ml HCG. |
| pH interference: Stable performance across a physiological pH range. | pH interference: Varying pH ranges (3 to 9 in 1 pH unit increments) did not interfere with test performance for 0mlU/ml and 25mlU/ml HCG samples. |
| Specific gravity interference: Stable performance across a physiological range of specific gravity. | Specific gravity interference: No interference was observed when specific gravity was between 1.01-1.04 for purified water and 25mIU/mL HCG spiked specimens. |
| Urinary system diseases interference: No interference from markers of urinary conditions. | Urinary system diseases interference: No interference observed from strongly positive white blood cells, urine occult blood, uric acid, and urine ketone in urine samples containing 0mlU/ml and 25mlU/ml HCG. |
| Hook effect: Maintain positive results at high HCG concentrations. | Hook effect: Generated positive results for HCG concentrations from 62,500mIU/ml to 1,000,000mIU/ml. (Note: "T line get to light as the concentration above 125000mlU/ml" indicates the test still works, but potentially with reduced band intensity, which is acceptable for qualitative detection and does not lead to false negatives at very high concentrations). |
| Method Comparison (Professional User): High agreement with predicate device results. | Professional Method Comparison (Strip, Cassette, Midstream - all methods): 100% agreement with the predicate device for all formats. (e.g., for Strip, Professional A: 38 Positive, 42 Negative; Professional B: 38 Positive, 42 Negative, all matching the predicate). |
| Method Comparison (Lay User): High agreement with professional test results. | Lay User Method Comparison (Strip, Cassette, Midstream - all methods): 100% agreement with professional laboratory results using the candidate device for all formats. (e.g., for Strip, Lay Users: 38 Positive, 42 Negative, all matching the professional results). |
| OTC User Performance: Untrained users can obtain correct results reliably. | OTC User Study: - Strip: 29/30 correct positive (31.25mIU/ml), 30/30 correct negative (18.75mIU/ml). - Cassette: 30/30 correct positive, 30/30 correct negative. - Midstream (dip): 30/30 correct positive, 30/30 correct negative. - Midstream (simulated midstream): 30/31 correct positive, 29/29 correct negative. Conclusion: Untrained operators can get correct results. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study: 30 clinical samples (normal, non-pregnant female urine) were spiked with HCG at 6 different concentrations (0mIU/ml, 12.5mIU/ml, 18.75mIU/ml, 25mIU/ml, 50mIU/ml, 100mIU/ml). Each concentration had 30 samples tested per LOT, across 3 lots, yielding 90 tests per concentration per format. The study was conducted over 10 days, 3 runs/day.
- Provenance: Clinical samples from "normal, non-pregnant females." The document does not explicitly state the country of origin, but the submitter is from Guangzhou, China, and the OTC user study sites are in Guangzhou, Shanghai, and Wuhan, suggesting a Chinese origin. The study appears to be a prospective experimental study using spiked samples.
- Specificity Study: 60 urine specimens (containing 0 mIU/ml and 25mIU/ml HCG) were spiked with LH, FSH, and TSH. Tested across 3 lots.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- Interfering Substances Study: Normal, non-pregnant female urine specimens (0 and 25 mIU/ml HCG) were spiked with 11 different compounds. 3 batches of each format were tested for each interferent.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- HCG ß-core fragment Interference Study: Normal, non-pregnant female urine specimens (0 and 25 mlU/ml HCG) were spiked with 4 different concentrations of HCG ß-core fragment. 3 batches of each format were tested.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- pH Interference Study: Aliquoted negative urine pool adjusted to pH 3-9, spiked with 0mlU/ml and 25mlU/ml HCG. 3 batches were tested repeatedly.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- Specific Gravity Interference Study: Purified water and 25mlUml HCG spiked specimens formulated with specific gravity 1.01-1.04. 3 lots tested.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- Urinary System Diseases Interference Study: Urine specimens with strongly positive markers (white blood cells, occult blood, uric acid, urine ketone) prepared with 0mlU/ml and 25mlU/ml HCG. 3 lots tested repeatedly.
- Provenance: Not explicitly stated, likely clinical samples. Prospective experimental study.
- HOOK Effect Study: HCG free specimens spiked with 5 different very high HCG concentrations (62,500mIU/m1 to 1,000,000mIU/ml). Three lots tested.
- Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
- Professional Method Comparison: 353 urine samples collected from women at a hospital laboratory. "Approximately half of the women were pregnant in the early stage of less than 5 weeks." Ages 18-45 years.
- Provenance: Clinical samples from a hospital laboratory. Not explicitly stated, but likely China given other study locations. Retrospective (samples collected, then tested) or prospective (samples collected specifically for the study) clinical study.
- Lay User Method Comparison: The same 353 urine samples as the Professional Method Comparison.
- Provenance: Clinical samples, likely China. Retrospective or prospective clinical study.
- Specific breakdown for lay users: 80 using strip, 113 using cassette, 160 using midstream (actual + dip methods combined).
- OTC User Performance: 240 female subjects (untrained operators, ages 18-45) tested masked spiked urine samples (120 containers of 18.75mlU/ml and 120 of 31.25mlU/ml). Each subject performed 1 test on one format/method.
- Provenance: Samples were spiked. Subjects from Guangzhou, Shanghai, and Wuhan, China. Prospective experimental study (simulated home use).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Precision, Specificity, Interference, pH, Specific Gravity, Urinary System Diseases, HOOK Effect Studies: The ground truth (HCG concentration, presence/absence of interferents) was established by spiking known concentrations of HCG or interfering substances, traceable to WHO standards or determined by immunoassay (ELISA). This does not involve human experts establishing ground truth for individual test samples, but rather analytical methods.
- Professional Method Comparison: The "ground truth" for this study was the result obtained by the predicate device when tested by laboratory professionals. The exact number of professionals is not specified, but the study was conducted at "two laboratories (namely Professional A and Professional B)", implying at least two professionals. Their qualifications are stated as "laboratory professionals."
- Lay User Method Comparison: The "ground truth" for this study was the result obtained by laboratory professionals using the candidate device. The number of laboratory professionals is not specified, but it was conducted at "a laboratory." Their qualifications are "laboratory professionals."
- OTC User Performance: The "ground truth" for this study was established by masked spiked urine samples (known HCG concentrations) and independently verified by professional laboratory personnel at the manufacturer site. The number of professionals is not specified, and their exact qualifications are not detailed beyond "professional laboratory personnel."
4. Adjudication Method for the Test Set
- For the analytical performance studies (Precision, Specificity, Interference, etc.), adjudication generally involves comparing the device's output to the known, spiked concentration or condition. There's no human adjudication process described beyond analytical confirmation of spike levels.
- For the Professional Method Comparison and Lay User Method Comparison, the comparison is against the predicate device or professional results of the candidate device. The agreement is tabulated directly, implying no specific "adjudication" if disagreement occurred, as 100% agreement was reported.
- For the OTC User Performance study, the lay users' results were compared against the "masked spiked sample professional users" results (i.e., known spiked concentration verified by professionals). Again, no specific adjudication process for discrepancies is described, as the focus is on the agreement rate.
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
There was no MRMC comparative effectiveness study done, as this device is a qualitative diagnostic test (HCG pregnancy test) not an imaging device typically analyzed by human readers with or without AI assistance. The studies involve human users (professional or lay) interpreting the test results visually, but not in a context typically requiring MRMC analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a visual qualitative immunochromatographic assay. There is no "algorithm" in the sense of a software-based AI. The performance is inherently "standalone" in that it produces a visual result (a line) and the interpretation is human-in-the-loop (reading the line). The "performance" studies are effectively standalone because they evaluate the test's ability to produce the correct visual output given an HCG concentration. The OTC user study then evaluates the human (lay user) interpretation of this visual output.
7. The Type of Ground Truth Used
- Spiked Samples (Precision, Specificity, Interference, Hook Effect, pH, Specific Gravity, Urinary System Diseases, OTC User Study): The ground truth was established by laboratory control, adding known concentrations of HCG (traceable to WHO 3rd IS) or interfering substances to urine samples. This is a form of analytical or engineered ground truth.
- Professional Method Comparison: The ground truth was the result from the predicate device.
- Lay User Method Comparison: The ground truth was the result from professional users testing the candidate device.
8. The Sample Size for the Training Set
There is no explicit training set described in this 510(k) summary. This type of device (lateral flow immunoassay) typically does not involve a machine learning model that requires a distinct "training set." The development process for such a device relies on chemical and biological engineering principles, optimization of reagents, and initial analytical testing, rather than an iterative machine learning training process with labeled data.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for a machine learning algorithm is mentioned, pertinent to the nature of this device, the question of how ground truth was established for a training set is not applicable. The ground truth for the performance evaluations (test sets) was established as described in section 7.
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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
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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 humanchorionic gonadotropin ("HCG") inurine | 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 |
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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 |
|---|---|---|---|
| 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 |
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
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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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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------- | -- | ----------- | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
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.
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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 deviceProfessional | ||
|---|---|---|---|
| Positive | Negative | ||
| Professional A | Positive | 38 | 0 |
| Negative | 0 | 42 |
5-6
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| Positive | |||
|---|---|---|---|
| Professional B | Positive | 38 | 0 |
| Negative | 0 | 42 |
The results of professional method comparison (cassette)
| Candidate device | Predicate deviceProfessional | ||||
|---|---|---|---|---|---|
| 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 deviceProfessional | ||
|---|---|---|---|
| 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 deviceProfessional | ||
|---|---|---|---|
| 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
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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 deviceProfessional | ||
|---|---|---|---|
| Positive | Negative | ||
| Layer users | Positive | 38 | 0 |
| Negative | 0 | 42 |
The results of the lay user method comparison (cassette)
| Candidate device | Candidate deviceProfessional | ||
|---|---|---|---|
| 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 deviceProfessional | ||
|---|---|---|---|
| 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
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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 sampleProfessional 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 dipmethod | Layer users | +(31.25mlU/ml) | 30 | 0 |
| -(18.75mlU/ml) | 0 | 30 | ||
| Midstream, using thesimulated midstreammethod | 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 ---
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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
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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
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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
§ 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.