(168 days)
The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).
The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:
- A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
- A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.
All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.
Devices are packaged one device per foil pouch and 25 devices in each kit.
Here's a breakdown of the acceptance criteria and study information for the Chemtrue® Human Chorionic Gonadotropin (hCG) Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a bulleted list prior to presenting results, but rather demonstrates performance against the intended claims (e.g., cutoff levels, agreement with predicate). Based on the performance data, the implicit acceptance criteria are that the device demonstrates comparable sensitivity and specificity to the predicate devices, and consistent performance across lots, sites, and operators.
Chemtrue® hCG Pregnancy Urine Dipstick Test & Cassette Test (Cutoff: 20 mIU/mL)
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Table 1-a, 1-b) |
|---|---|---|
| Sensitivity Study | 100% detection at 20 mIU/mL and above; 0% detection at 0 and 10 mIU/mL | 20 mIU/mL (Cutoff): 15/15 positive (100%) for all lots/formats40 mIU/mL: 15/15 positive (100%) for all lots/formats80 mIU/mL: 15/15 positive (100%) for all lots/formats0 mIU/mL: 0/15 positive (0%) for all lots/formats10 mIU/mL (-50% Cutoff): 0/15 positive (0%) for all lots/formats15 mIU/mL (-25% Cutoff): 3/15 positive for all lots/formats |
| Method Comparison (vs. Predicate K990578) | High agreement (e.g., >95%) with predicate in detecting positive and negative samples. | Dipstick (Table 8): Sensitivity 100% (150/150), Specificity 100% (150/150), Total Agreement 100% (300/300)Cassette (Table 9): Sensitivity 100% (149/149), Specificity 99.3% (150/151), Total Agreement 99.7% (299/300) |
| Reproducibility (Cutoff: 20 mIU/mL) | Consistent results across sites and operators, especially at and around cutoff. | 20 mIU/mL (Cutoff): 27/27 positive at all 3 sites and for both Dipstick and Cassette formats (100% agreement).15 mIU/mL (-25% cutoff): Dipstick: 3/27 positive; Cassette: 2/27 positive. (Shows expected variability below cutoff).Within Site Agreement: 100% (Site 1, 3), 99.5% (Site 2)Between Sites Agreement: 99.8% |
| High Dose Hook Effect | No false negatives at high hCG concentrations. | No hook effect observed up to 500 IU/mL (500,000 mIU/mL). (Table 14) |
| Analytical Specificity / Cross-Reactivity | No significant interference from tested substances at specified concentrations. | No cross-reactivity with hLH, hFSH, hTSH, or other common interfering substances (Tables 13, 14-a, 15-a, 15-b). No interference from hCGBcf up to 1,000,000 pmol/mL. |
| pH and Specific Gravity | Consistent performance across physiological pH and specific gravity ranges. | No interference observed for pH 2.0-9.0 and SG 1.003-1.030. |
Chemtrue® hCG Combo (Serum/Urine) Cassette Test (Cutoff: 25 mIU/mL)
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Tables 2-a, 2-b) |
|---|---|---|
| Sensitivity Study | 100% detection at 25 mIU/mL and above; 0% detection at 0 and 10 mIU/mL (urine) / 0, 10, 20 mIU/mL (serum) | 25 mIU/mL (Cutoff): 15/15 positive (100%) for all lots/formats50 mIU/mL: 15/15 positive (100%) for all lots/formats100 mIU/mL: 15/15 positive (100%) for all lots/formats0 mIU/mL: 0/15 positive (0%) for all lots/formats10 mIU/mL (-60% Cutoff): 0/15 positive (0%) for all lots/formats20 mIU/mL (-20% Cutoff): 3/15 positive (Urine), 3/15 positive (Serum) |
| Method Comparison (vs. Predicate K964461) | High agreement (e.g., >95%) with predicate in detecting positive and negative samples. | Serum (Table 10): Sensitivity 100% (150/150), Specificity 100% (150/150), Total Agreement 100% (300/300)Urine (Table 11): Sensitivity 100% (150/150), Specificity 100% (150/150), Total Agreement 100% (300/300) |
| Reproducibility (Cutoff: 25 mIU/mL) | Consistent results across sites and operators, especially at and around cutoff. | 25 mIU/mL (Cutoff): 27/27 positive at all 3 sites and for both Urine and Serum formats (100% agreement).20 mIU/mL (-20% cutoff): Urine: 5/27 positive; Serum: 5/27 positive. (Shows expected variability below cutoff).Within Site Agreement: 100% (Site 1, 3), 99.5% (Site 2)Between Sites Agreement: 99.8% |
| High Dose Hook Effect | No false negatives at high hCG concentrations. | No hook effect observed up to 500 IU/mL (500,000 mIU/mL). (Table 15) |
| Analytical Specificity / Cross-Reactivity | No significant interference from tested substances at specified concentrations. | No cross-reactivity with hLH, hFSH, hTSH, or other common interfering substances (Tables 13, 14-a, 15-a, 15-b). No interference from hCGBcf up to 1,000,000 pmol/mL. |
| pH and Specific Gravity | Consistent performance across physiological pH and specific gravity ranges. | No interference observed for pH 2.0-9.0 and SG 1.003-1.030. |
2. Sample Size Used for the Test Set and Data Provenance
-
Sensitivity (Cutoff Characteristics) Study:
- Sample Size: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. For each lot, 6 hCG concentration levels (0, 10, 15, 20, 40, 80 mIU/mL for urine tests; 0, 10, 20, 25, 50, 100 mIU/mL for combo tests) were used with 5 replicates each.
- Total for Urine tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per urine format (Dipstick, Cassette)
- Total for Combo tests: 3 lots * 6 concentrations * 5 replicates = 90 tests per Combo format (Urine, Serum)
- Data Provenance: Spiked hCG urine/serum pools from non-pregnant donors. The origin of the donors/samples is not specified (e.g., country), but they are described as "human urine pool from non-pregnant donors" and "non-pregnant human serum and urine pools." This is a prospective spiking study.
- Sample Size: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. For each lot, 6 hCG concentration levels (0, 10, 15, 20, 40, 80 mIU/mL for urine tests; 0, 10, 20, 25, 50, 100 mIU/mL for combo tests) were used with 5 replicates each.
-
Reproducibility (Precision) Study:
- Sample Size:
- For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested.
- 7 hCG concentration levels for urine (0, 10, 15, 20, 25, 30, 35 mIU/mL) and 6 for serum (0, 15, 20, 25, 30, 35 mIU/mL).
- Tested over 3 non-consecutive days with 3 operators per site across 3 sites. Each operator tested each control level (implied that 1 replicate for each level was run by each operator per day).
- Calculation per device format and concentration level: 3 lots * 3 sites * 3 operators = 27 data points.
- Data Provenance: Spiked hCG urine/serum controls, calibrated against WHO 5th IS, confirmed with Abbott i2000 instrument. The study was conducted at "three (3) POL sites." The geographical location of these POL sites is not explicitly stated. This is a prospective spiking study.
- Sample Size:
-
Method Comparison Study:
- Sample Size:
- Urine: 300 clinical urine samples (150 hCG negative, 150 hCG positive).
- Serum: 100 clinical serum samples (50 hCG negative, 50 hCG positive).
- Data Provenance: Clinical samples from women who were suspected to be pregnant or non-pregnant women of childbearing age (including peri-menopausal). The study was conducted at "three (3) POL sites... in Shanghai China." The data is retrospective clinical samples (but prospective testing with the device).
- Sample Size:
-
Analytical Specificity (Cross-reactivity) Study:
- Sample Size: For each device format, 3 lots were tested. hLH, hFSH, hTSH, and other interfering substances were spiked into hCG negative and 50 mIU/mL controls (number of replicates not explicitly stated for all, but typically done in replicates).
- hCGBcf interference: For each device format (Dipstick, Cassette, Combo Urine, Combo Serum), 3 lots were tested. 5 and 50 mIU/mL hCG controls were spiked with 4 hCGBcf concentrations. 10 replicates for each condition were tested (e.g., 3 lots * 2 hCG concentrations * 4 hCGBcf concentrations * 10 replicates = 240 tests for Dipstick, and similarly for other formats).
- Data Provenance: Spiked samples.
-
High Dose (Hook Effect) Study:
- Sample Size: For each device format (Urine Tests: Dipstick, Cassette; Combo Tests: Urine, Serum), 3 lots were used. 5 hCG concentrations (50, 100, 200, 300, 500 IU/mL) were tested with 5 replicates per lot.
- Total for Urine tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per urine format.
- Total for Combo tests: 3 lots * 5 concentrations * 5 replicates = 75 tests per combo format.
- Data Provenance: Spiked non-pregnant urine and serum pools.
- Sample Size: For each device format (Urine Tests: Dipstick, Cassette; Combo Tests: Urine, Serum), 3 lots were used. 5 hCG concentrations (50, 100, 200, 300, 500 IU/mL) were tested with 5 replicates per lot.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test sets (except method comparison and analytical specificity, discussed below) was established by spiking known concentrations of hCG into negative samples, and these concentrations were "quantitatively confirmed by Abbott i2000 instrument." This means there were no human experts establishing ground truth for the spiked studies.
For the Method Comparison Study:
- The "hCG positive serum samples were quantitatively confirmed by Abbott i2000 instrument." This establishes a quantitative ground truth for positive samples.
- The "150 hCG negative urine samples (collected from women of childbearing age, including peri-menopausal)" and "50 hCG negative serum samples" implicitly had their negative status confirmed, likely through prior testing or knowledge that they were from non-pregnant individuals.
- For the comparison itself, the predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test (K990578) and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test (K964461)) served as the reference standard against which the new devices were compared. The predicate devices themselves would have been cleared based on their own performance against a ground truth. No specific "experts" are mentioned as establishing ground truth for this comparative study beyond the established performance of the predicate and quantitative instrumentation.
For Analytical Specificity (Cross-reactivity): The "ground truth" was the known presence of specific interfering substances and the known absence or presence of hCG at specific concentrations.
4. Adjudication Method for the Test Set
- Sensitivity, Reproducibility, High Dose, Analytical Specificity, and pH/SG studies: The results were interpreted at 5 minutes by the "same operator" who performed the test in the reproducibility study. In the sensitivity study, "three (3) operators" tested the samples. These studies used objective criteria (presence/absence of a line) and known hCG concentrations, so an explicit adjudication method beyond visual interpretation by the operator (or in some cases, multiple operators) is not described or typically required for this type of qualitative assay performance testing using spiked samples.
- Method Comparison Study: "Each specimen was evenly split into three aliquots. Each site tested 100 samples with a unique set of blind codes for each device formation." The test device's result was then compared to the predicate device's result. Discrepancies are noted (e.g., "One discrepant result in this table was from a single sample with a hCG concentration near the cut-off"). No explicit multi-reader adjudication method (like 2+1) is mentioned, as the comparison is against an established predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a formal MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with and without AI assistance. This document describes a traditional in-vitro diagnostic (IVD) device (a lateral-flow immunoassay) which is interpreted visually by a human. The studies performed are standard IVD performance characteristic studies.
The "Method Comparison Study" involved multiple operators (9 operators across 3 sites in Shanghai, China), but this was comparing the device's performance to a predicate device, not comparing human reader effectiveness with and without AI. It demonstrated that human readers could use the new device to achieve results comparable to predicate devices. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in essence, the fundamental performance characteristics (Sensitivity/Cutoff, Analytical Specificity, High Dose, pH/SG, Stability) of the device itself were tested in a standalone manner by evaluating its ability to correctly identify various concentrations of hCG or detect interfering substances, independent of human variability in clinical settings. These are tests of the device's inherent analytical performance.
However, since this is a visually-read qualitative immunoassay, the final "output" is inherently derived from human observation. The "Reproducibility (Precision) Study" assessed the consistency of this human observation across multiple users and sites, ensuring that the human-in-the-loop interpretation provided reliable results.
7. The Type of Ground Truth Used
- For Sensitivity/Cutoff, Reproducibility, Analytical Specificity, High Dose, pH/SG studies: The ground truth was known concentrations of hCG or other substances that were quantitatively confirmed by a reference instrument (Abbott i2000) or laboratory standards (WHO 5th IS 07/364). This is considered an analytical ground truth based on spiked samples.
- For Method Comparison Study: The ground truth for clinical samples was established by comparison against legally marketed predicate devices (Genzyme Diagnostics OSOM® Card hCG Urine Test and Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test). For serum samples, the hCG positive status was also quantitatively confirmed by an Abbott i2000 instrument. This is a comparative ground truth against an existing, cleared device, supported by quantitative confirmation for positives.
8. The Sample Size for the Training Set
The document describes the submission as a premarket notification (510(k)) for a new device. It does not explicitly mention a "training set" in the context of machine learning algorithms. This device is a lateral flow immunoassay, which does not typically involve training a computational algorithm. The studies described are performance validation studies for the finished device.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of a machine learning algorithm, this question is not applicable. The device's fundamental design is based on immunological principles, not learned from a dataset.
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MAY 3 0 2013
Final 510(k) Summary
(K123844)
Chemtrue® Human Chorionic Gonadotropin (hCG) Pregnancy Test
With the following configurations:
- Chemtrue® hCG Pregnancy Urine Dipstick Test 1.
-
- Chemtrue® hCG Pregnancy Urine Cassette Test
- Chemtrue® hCG Combo (Serum/Urine) Cassette Test 3.
Prepared By: Jane Zhang, Director of QA/RA Sponsor: Chemtron Biotech, Inc. 8370 Juniper Creek Lane, Suite 1-2 San Diego, CA 92126 Office phone: (858) 530-2868 Mobile phone: (858) 997-7472 Fax (858) 530-2878
Date: May 30, 2013
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510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
The Assigned 510(k) number is K123844
Date of Summary: May 30, 2013
Purpose for Submission: New Device
Measurand: Human Chorionic gonadotropin (hCG) in human urine / serum
Type of Test: Qualitative
Applicant: Chemtron Biotech, Inc.
Trade/Proprietary Name:
Chemtrue® hCG Pregnancy Urine Dipstick Test Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test
Regulatory Information:
-
- Regulation section: 21CFR §862.1155, human chorionic gonadotropin (hCG) test system.
-
- Identification: An hCG test system is intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine or serum.
-
- Classification: II
- Product code: JHI
Panel: Clinical Chemistry (75)
Proposed Labeling or Promotional Material for the Device:
A description of the device can be found in the attached proposed labeling, including an explanation of how the device functions, technical principle and concepts that form the basis for the device, as well as the physical and performance characteristics of the device, such as the device design, materials used and physical properties. In accordance with FDA labeling requirements (21 CFR 809.10), enclosed are the draft copies of product labeling including copies of the technical product inserts.
Intended Use
See indications for use below. The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).
Indication(s) for Use:
Chemtrue® hCG Pregnancy Urine Dipstick Test
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The Chemtrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
Chemtrue® hCG Pregnancy Urine Cassette Test
The Chemtrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
Chemtrue hCG Combo (Serum/Urine) Cassette Test
The Chemtrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only.
The test kits are for prescription use including professionals office laboratories (POLS) or Point-Of-Care site (POC).
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Special conditions for use statement(s):
The devices are for prescription use.
Special instrument requirements: None
Device Description:
The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:
-
- A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
-
- A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.
All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.
Devices are packaged one device per foil pouch and 25 devices in each kit.
Human source materials was tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HbsAg and HCV.
Substantial Equivalence Information:
The Chemtrue® hCG Pregnancy Urine Dipstick/Cassette Test and hCG Combo Test are substantially equivalent to other tests currently on the market.
- Predicate device name(s) and 510(k) number(s):
| Predicate Device Name | 510(k) k number |
|---|---|
| Genzyme Diagnostics OSOM® Card hCG Urine Test | K990578 |
| Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test | K964461 |
- Comparison with predicate:
The Chemtrue® hCG Pregnancy test device is similar to the predicate(s) with regard to the technology principle, indication for use, detection limit and sample matrix, etc. The candidate device and the predicates are both visually-read single use devices. The similarities and differences among these tests are summarized as follows:
2-a. hCG urine Tests:
| Item | SIMILARITIES | |
|---|---|---|
| Proposed Device | Predicate Device | |
| Item | Chemtrue® hCG PregnancyUrine Tests | OSOM® Card hCG Urine TestK990578 |
| Intended Use | A rapid qualitative immunoassayfor rapid determination of | Same |
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:
| human chorionic gonadotropin(hCG) to aid in the earlydetection of pregnancy | ||
|---|---|---|
| Technology principle | Lateral-flow immunoassay | Same |
| Indication of Use | For prescription use, includingprofessionals at physician'soffice labs (POLs) | Same |
| Specimen matrix | Human urine | Same |
| Results | Qualitative | Same |
| Result Interpretation | Visually-read line intensity | Same |
| Sensitivity/Cutoff characteristics | 20 mIU/mL | Same |
| Quality Control | Built-in Internal Control | Same |
| DIFFERENCES | ||
|---|---|---|
| Item | Proposed Device | Predicate Device |
| Chemtrue® hCG Pregnancy | OSOM® Card hCG Urine Test | |
| Urine Test | K990578 | |
| Read time | Read the results at 5 minutes. | Read the results at 3 minutes. |
| Device format | Dipstick and Cassette | Cassette only |
| Storage | 4°C - 30°C | 15°C -30°C |
2-b. hCG Combo Test:
| SIMILARITIES | ||
|---|---|---|
| Proposed DeviceChemtrue® hCG Combo(Urine/Serum) Cassette Test | Predicate DeviceTeco Diagnostics One-StepUrine/Serum Combo PregnancyCard Test K964461 | |
| Item | ||
| Intended Use | A rapid qualitative immunoassayfor rapid determination ofhuman chorionic gonadotropin(hCG) to aid in the earlydetection of pregnancy | Same |
| Technology principle | Lateral-flow immunoassay | Same |
| Indication of Use | For prescription use, includingprofessionals at physician'soffice labs (POLs) | Same |
| Specimen matrix | Human urine or serum | Same |
| Results | Qualitative | Same |
| Result Interpretation | Visually-read line intensity | Same |
| Read time | Read the results at 5 minutes | Same |
| Sensitivity/Cutoff characteristics | 25 mIU/mL | Same |
| Quality Control | Built-in Internal Control | Same |
| A to many as and i an i a caLEAR S. MINE MAR LIESTHE ORDENCES------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|
| ltemsAnd And Analy Company of Children Comments of Children Comments of Children------------------------ | Pronosed Device | 1CPredicate Device |
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| Chemtrue® hCG Combo(Urine/Serum) Test | Teco Diagnostics One-StepUrine/Serum Combo PregnancyCard Test K964461 | |
|---|---|---|
| Storage | 4°C – 30°C | 18°C - 30°C or refrigerated (2-8°C) |
Standard/Guidance Document Referenced (if applicable):
- FDA guidance: Review Criteria for Assessment of Professional Use Human Chorionic . Gonadotropin (hCG) In Vitro Diagnostic Devices - Document Issued on: November 6, 1996.
- National Committee for Clinical Laboratory Standards. Evaluation of precision performance of . clinical chemistry devices; tentative guideline - Second Edition. NCCLS Document EP5-T2. Wayne, PA: NCCLS, 1992.
- CLSI EP7-A2: Interference Testing in Clinical Chemistry ●
- ISO 14971:2007, Medical Devices-Application of Risk Management to Medical Devices .
Test Principle:
The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine and or serum. Monoclonal for hCG Combo) goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antimouse antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip.
Performance Characteristics
Chemtron Biotech, Inc. has reviewed the FDA guidance documents "Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) -Document Issued on: November 6, 1996" and CFR809.10 labeling regulations and conducted the studies listed in the notification were conducted, including the design of draft labeling and package inserts.
- Sensitivity (Cutoff Characteristics): Three (3) lots of each device formats were used for the study with spiked hCG urine pool from non-pregnant donors. The hCG was traceable to WHO 50 IS (07/364) at the concentrations of 0, 10,15,20,40 and 80 mIU/mL. The hCG concentrations were quantitatively confirmed by Abbott i2000 instrument. The controls were blind coded. Separate sets of the blind codes were assigned for each device format, Dipstick, Cassette and hCG Combo Test. Five (5) replicates
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were tested at each hCG control level by three (3) operators at 5 minutes as the read time, per package insert request. The results are summarized in tables below:
| hCG Conc.(mIU/mL) | # of SamplesTested | Lot 1 | Lot 2 | Lot 3 | # of Positives | |||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | |||
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-50% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 15 (-25% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 20 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 40 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 80 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
Table 1-a. Results of Chemtrue® hCG Dipstick Pregnancy Test:
Table 1-b. Results of Chemtrue® hCG Cassette Pregnancy Test:
| hCG Conc.(mIU/mL) | # of SamplesTested | Lot 1 | Lot 2 | Lot 3 | # of Positives | |||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | |||
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-50% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 15 (-25% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 20 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 40 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 80 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
Chemtrue® hCG Combo Test: Three (3) lots of test devices were used for the study. The controls were prepared using spiked hCG in twenty (20) non-pregnant human serum and urine pools, respectively. The hCG controls were traceable to WHO 5th IS (07/364). The following six (6) hCG concentrations were used for the study:
| hCG Concentration (mIU/mL) in Serum | hCG Concentration (mIU/mL) in Urine |
|---|---|
| 0 | 0 |
| 10 | 10 |
| 20 | 20 |
| 25 | 25 |
| 50 | 50 |
| 100 | 100 |
Results:
Table 2-a. Chemtrue® hCG Combo (Urine) Test:
| hCG Conc. (mIU/mL) | # of Samples Tested | Lot 1 | Lot 2 | Lot 3 | # of Positives | |||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | |||
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-60% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 20 (-20% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 25 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 50 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 100 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
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| hCG Conc.(mIU/mL) | # of SamplesTested | Lot 1 | Lot 2 | Lot 3 | # of Positives | |||
|---|---|---|---|---|---|---|---|---|
| 0 | 15 | + | - | + | - | + | - | |
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-60% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 20 (-20% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 25 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 50 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 100 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
Table 2-b. Chemtrue® hCG Combo (Serum) Test:
CONCLUSION: The results confirmed the claimed cutoff (sensitivity/detection limit) levels for the Chemtrue " hCG Tests in Dipstick/Cassette configurations, as well as the hCG Combo Test. Also the results demonstrated that the functional performance is consistent between lot-to-lot of all the device formats/ configurations.
Linearity/assav reportable range: Linearity is not applicable since this is a qualitative test.
Traceability, Stability, Expected values (controls, calibrators, or methods): Chemtrue® hCG Pregnancy Tests are calibrated against reference material traceable to WHO International Standard 5th edition.
A shelf-life stability test of the devices was performed in real-time and accelerated testing. The results showed that the devices were stable for 24 months when stored at 25°C±2°C in the sealed foil pouch. Protocol and acceptance criteria were reviewed and are acceptable.
The sensitivity was evaluated in conjunction with the Cut-off characteristics and precision testing. Refer to the precision data in section 2 below. The detection limit was demonstrated to be 20 mIU/mL for urine test and 25 mIU/mL for hCG Combo test.
- Reproducibility (Precision) Study: The study was conducted in three (3) POL sites by a total of nine (9) operators and three (3) operators for each site with three (3) lots of each proposed device formats over three (3) non-consecutive days. The blind coded controls were used with hCG spiked at the concentrations of 0, 10, 15, 20, 25, 30 and 35 mIU/mL in urine; 0, 15, 20, 25, 30 and 35 mIU/mL in serum (Used for hCG Combo Test). The controls were calibrated against WHO 50" IS (07/364) and the values were confirmed with a FDA cleared Abbott chemiluminescent quantitative immunoassay, i2000 (Abbott Park, Illinois, 60064-3500, U.S.A). Every device was tested and interpreted by the same operator at 5 minutes as the read time, per package insert request. The reproducibility between the sites is summarized in tables below:
| Sites | TOTAL | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | + | - | |||||
| hCGconcentration(mIU/mL) | Spec. | + | - | + | - | + | - | + | - |
| 0 | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| 10 (-50%cutoff) | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| 15 (-25%cutoff) | 1 | 8 | 1 | 8 | 1 | 8 | 3 | 24 |
Table 3: hCG Dipstick Test (Cut-off 20 mIU/mL)
{8}------------------------------------------------
Chemtron Biotech, Inc. Final 510(k) Summary K123844
| 20 (Cut-off) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
|---|---|---|---|---|---|---|---|---|
| 25 (+25%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
| 30 (+50%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
| 35 (+75%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
Table 4. hCG Cassette Test (Cut-off 20 mIU/mL)
| Sites | TOTAL | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | |||||||
| Spec. | + | - | + | - | + | - | + | - | |
| hCGconcentration(mIU/mL) | 0 | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 |
| 10 (-50%cutoff) | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| 15 (-25%cutoff) | 0 | 9 | 1 | 8 | 1 | 8 | 2 | 25 | |
| 20 (Cut-off) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 25 (+25%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 30 (+50%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 35 (+75%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
Table 5. hCG Combo Urine Test (Cut-off 25 mIU/mL)
| Sites | TOTAL | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | + | - | |||||
| Spec. | + | - | + | - | + | - | + | - | |
| hCGconcentration(mIU/mL) | 0 | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 |
| 15 (-40% cutoff) | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| 20 (-20% cutoff) | 1 | 8 | 2 | 7 | 2 | 7 | 5 | 22 | |
| 25 (Cut-off) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 30 (+20% cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 35 (+40% cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
Table 6. hCG Combo Serum Test (Cut-off 25 mIU/mL)
| Sites | TOTAL | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Spec. | 1 + | 1 - | 2 + | 2 - | 3 + | 3 - | + | - | |
| 0 | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| hCGconcentration(mIU/mL) | 15 (-40% cutoff) | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 |
| 20 (-20% cutoff) | 2 | 7 | 1 | 8 | 2 | 7 | 5 | 22 | |
| 25 (Cut-off) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 30 (+20% cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 35 (+40% cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
{9}------------------------------------------------
| Configurations | TOTAL | ||||||
|---|---|---|---|---|---|---|---|
| Spec. | Cassette + | Cassette - | Dipstick + | Dipstick - | + | - | |
| hCGconcentration(mIU/mL) | 0 | 0 | 27 | 0 | 27 | 0 | 54 |
| 10 (-50%cutoff) | 0 | 27 | 0 | 27 | 0 | 54 | |
| 15 (-25%cutoff) | 2 | 25 | 3 | 24 | 5 | 49 | |
| 20 (Cut-off) | 27 | 0 | 27 | 0 | 54 | 0 | |
| 25 (+25% cutoff) | 27 | 0 | 27 | 0 | 54 | 0 | |
| 30 (+50% cutoff) | 27 | 0 | 27 | 0 | 54 | 0 | |
| 35 (+75% cutoff) | 27 | 0 | 27 | 0 | 54 | 0 |
| Table 7. Comparison among two device formats for Chemtrue® hCG urine Tests | |||
|---|---|---|---|
CONCLUSION: The results demonstrate a consistent functional performance of the Chemtrue® hCG Tests between the sites and device formats/configurations.
Reproducibility study data among the operators: The results demonstrate that the performance of each Chemtrue® hCG Test format was similar between nine (9) operators across all three (3) study sites.
- Method Comparison Study Data Summary: Chemtrue® hCG Pregnancy Tests were compared with the Predicate kits. A total of 300 clinical urine samples were blind coded and tested with each device format by nine (9) operators from three (3) POL sites (three operators in each site) in Shanghai China. One hundred-fifty (150) hCG negative urine samples (collected from women of childbearing age, including peri-menopausal) and 150 hCG positive samples that represented women who were suspected to be pregnant within the first 30 days of pregnancy/the first trimester of pregnancy in the early pregnancy and late pregnancy. 50 hCG negative serum samples and 50 hCG positive serum samples that are representative for the populations of the intended use were used for the study. The hCG positive serum samples were quantitatively confirmed by Abbott i2000 instrument. Each specimen was evenly split into three aliquots. Each site tested 100 samples with a unique set of blind codes for each device formation. The results are summarized in tables below: Table 8. Chemtrue hCG Pregnancy Urine Dipstick Test (Cutoff: 20 mIU/mL)
| Predicate DeviceOSOM® Card hCG Urine Test (K990578) | Total Agreement% | |||
|---|---|---|---|---|
| Positive | Negative | |||
| Chemtrue® hCGDipstick TestN=300 | Positive | 150 | 0 | |
| Negative | 0 | 150 | 100% | |
| Total | 150 | 150 |
Sensitivity = (150 / (60+90)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100% Table 9. Chemtrue " hCG Pregnancy Urine Cassette Test (Cutoff: 20 mIU/mL)
| Predicate DeviceOSOM® Card hCG Urine Test (K990578) | Total Agreement% |
|---|---|
| Positive | Negative |
{10}------------------------------------------------
| Chemtrue® hCG | Positive | 149 | ||
|---|---|---|---|---|
| Cassette Test | Negative | 1 20 | 99.7% | |
| N=300 | Total | 150 | 150 | |
| ् | 11 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 14 20 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 1 4 A A 4AA AAI |
Sensitivity = (149 / (59+90+0)) x100 = 100%; Specificity = (150 / (150+1)) x 100 = 99.3%
One discrepant result in this table was from a single sample with a hCG concentration near the cut-off of the device (20 mIU/mL).
Table 10. Chemtrue® hCG Combo Pregnancy Serum Test (Cutoff: 25 mIU/mL)
| Predicate DeviceOne-Step Urine/Serum Combo Pregnancy Card Test(K964461) | TotalAgreement | |||
|---|---|---|---|---|
| Positive | Negative | |||
| Chemtrue® hCGCombo Serum TestN=300 | Positive | 150 | 0 | |
| Negative | 0 | 150 | 100% | |
| Total | 150 | 150 |
Sensitivity = (150 / (12+138)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100%
Table 11. Chemtrue® hCG Combo Pregnancy Urine Test (Cutoff: 25 mIU/mL)
| Predicate DeviceOne-Step Urine/Serum Combo Pregnancy Card Test(K964461) | TotalAgreement | |||
|---|---|---|---|---|
| Positive | Negative | |||
| Chemtrue® hCGCombo Urine TestN=300 | Positive | 150 | 0 | |
| Negative | 0 | 150 | 100% | |
| Total | 150 | 150 |
Sensitivity = (150 / (60+90)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100%
Discussion and Conclusion: Based on the technological principle, features of the device design, test specimen matrix, test method and performance characterizations, as the set forth above, it can be concluded that Chemtrue® hCG Pregnancy tests are substantially equivalent to the predicate kits which are currently distributed commercially.
Table 12. Accuracy assessment within site and between sites:
| Site 1 | Site 2 | Site 3 | ||
|---|---|---|---|---|
| Agreement | Within Site | 100% | 99.5% | 100% |
| Between Sites | 99.8% |
Conclusion: The results demonstrate an overall 99.8% agreement within the site and between the sites. The device performance is substantially equivalent to the predicate kit OSOM® Card Pregnancy Test and other products that are presently distributed commercially.
4. Clinical studies:
{11}------------------------------------------------
a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
-
- Clinical cut-off: Not applicable
-
- Expected values/Reference range: Not applicable
- Analytical specificity: The cross-reactivity study was conducted with three (3) lots of each test format/configuration with spiked concentration of the structurally related or potential interfering substances in urine and serum hCG negative and 50 mIU/mL controls. The results demonstrate that the Chemtrue® hCG Tests do not cross react with hLH up to 300 mIU/mL, hFSH up to 1000 mIU/mL and hTSH up to 1000 mIU/mL. The following compounds do not interfere with Chemtrue® hCG Tests at the concentrations tested:
| 1 | able | 13. | ||
|---|---|---|---|---|
| Substance | Concentration |
|---|---|
| Acetylsalicylate Acid | 20 mg/dL |
| Albumin (Human) | 2000 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Bilirubin | 2 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| Ephedrine | 20 mg/dL |
| Gentisic Acid | 20 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 250 mg/dL |
| Ibuprofen | 40 mg/dL |
| Methadone | 10 mg/dL |
| Morphine | 6 $\mu$ g/dL |
| Phenylpropanolamine | 20 mg/dL |
| Salicylic acid | 20 mg/dL |
| Uric Acid | 20 mg/dL |
The detailed data is summarized in Section "Performance Characteristics, Specificity", page 56 of 510(k) Submission.
An interference study with hCGBcf was also performed with three (3) lots each format at the concentrations 125,000, 250,000, 500,000 and 1,000,000 pmol/mL of hCGlocf that were added into 5 and 50 mIU/mL hCG urine and serum controls. The results are summarized in Table 14 below:
{12}------------------------------------------------
| 125,000 pmol/mL | 250,000 pmol/mL | 500,000 pmol/mL | 1,000,000 pmol/mL | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| hCG Conc.in urine | Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | |
| 5 mIU/mL | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | |
| 50 mIU/mL | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
Table 14-a. Interference study results with hCGBcf - Urine Dipstick Test
| # of Positive Results with Concentrations of hCG βcf | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125,000 pmol/mL | 250,000 pmol/mL | 500,000 pmol/mL | 1,000,000 pmol/mL | |||||||||
| hCG Conc.in urine | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 |
| 5 mIU/mL | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 |
| 50 mIU/mL | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
Table 15-a. Interference study results with hCGBcf - hCG Combo Urine Test
| # of Positive Results with Concentrations of hCG βcf in Urine | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125,000 pmol/mL | 250,000 pmol/mL | 500,000 pmol/mL | 1,000,000 pmol/mL | |||||||||
| hCG Conc.in urine | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 | Lot#1 | Lot#2 | Lot#3 |
| 5 mIU/mL | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 |
| 50 mIU/mL | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
Table 15-b. Interference study results with hCGBcf - hCG Combo Serum Test
| # of Positive Results with Concentrations of hCG βcf in Serum | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| hCG Conc.in Serum | 125,000 pmol/mL | 250,000 pmol/mL | 500,000 pmol/mL | 1,000,000 pmol/mL | ||||||||
| Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | Lot #1 | Lot #2 | Lot #3 | |
| 5 mIU/mL | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 |
| 50 mIU/mL | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
CONCLUSION: The results demonstrate that hCGBcf up to 1,000,000 pmol/mL does not interfere with the Chemtrue® hCG Tests.
The effect of specific gravity (SG) and pH were evaluated by testing duplicates at each sample level of hCG negative and 20 mIU/mL (25 mIU/mL for Combo Test) urine controls with pH 2.0 to 9.0, and SG of 1.003 to 1.030. No interference was observed for pH value 2.0 to 9.0 and SG values from 1.003 to 1.030. However, labeling states that low concentrations of hCG may not be detected in very dilute urine and, if pregnancy is suspected, testing should be repeated after 48 hours. The detailed data is enclosed in ATTACHMENT D, page 74 of the submission.
Flex studies were performed and include read time and sample volume verifications. The results support the claims in the package inserts. The study reports are presented in ATTACHMENT H, pages H9 to H25 of the submission.
{13}------------------------------------------------
- High dose (hook effect): The studies for both hCG Urine and Combo Tests were performed on three (3) lots of each test format with spiked non-pregnant urine and serum pools at hCG concentrations of 50, 100, 200, 300 and 500 IU/mL. Five replicates of each lot were tested at each hCG concentration. The results are summarized in Table 14 and 15 below:
Table 14. High Dose Effect Study Results Summary with hCG Urine Tests
| hCG Concentrations(IU/mL) | hCG Urine Tests | |||
|---|---|---|---|---|
| Dipstick | Cassette | |||
| + | - | + | - | |
| 50 | 15 | 0 | 15 | 0 |
| 100 | 15 | 0 | 15 | 0 |
| 200 | 15 | 0 | 15 | 0 |
| 300 | 15 | 0 | 15 | 0 |
| 500 | 15 | 0 | 15 | 0 |
| TOTAL | 75 | 0 | 75 | 0 |
Table 15. High Dose Effect Study Results Summary with hCG Combo (Urine/Serum) Test
| hCGConcentrations(IU/mL) | hCG Combo Tests | |||
|---|---|---|---|---|
| Urine Test | Serum Test | |||
| + | - | + | - | |
| 50 | 15 | 0 | 15 | 0 |
| 100 | 15 | 0 | 15 | 0 |
| 200 | 15 | 0 | 15 | 0 |
| 300 | 15 | 0 | 15 | 0 |
| 500 | 15 | 0 | 15 | 0 |
| TOTAL | 75 | 0 | 75 | 0 |
Conclusion: No hook effect was observed with hCG concentrations up to 500 1U/mL in urine and serum for hCG urine and Combo tests in all the formats.
CONCLUSION:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
{14}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
Chemtron Biotech, Inc. C/O Ms. Jane Zhang 8370 Juniper Creek Lane, Suite 1-2 SAN DIEGO CA 92126
Re: K123844
Trade/Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test
Chemtrue® hCG Combo (Serum/Urine) Cassette Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: April 29, 2013 Received: May 3, 2013
Dear Ms. Zhang:
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. 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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{15}------------------------------------------------
Page 2-Ms. Zhang
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/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
{16}------------------------------------------------
Indications for Use
510(k) Number (if known): K123844
· Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test
Indications for Use:
Chemtrue hCG Pregnancy Urine Dipstick Test
The Chemtrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
Chemtrue® hCG Pregnancy Urine Cassette Test
The Chemtrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of-pregnancy .- The device is intended for Prescription Use. Only .-
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(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-Ivles -S 2013.05.30 11:07:17 -04′00″
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123844
{17}------------------------------------------------
Indications for Use
510(k) Number (if known): K123844
Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test
Indications for Use:
Chemtrue® hCG Combo (Serum/Urine) Cassette Test:
The Chemtrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only.
The test kits are for prescription use including professionals at physician's office laboratories (POLs) or Point-Of-Care site (POC).
And/Or
Prescription Use X (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(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 2013.05.30 11:07:40 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123844
§ 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.