INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Q: Who is the manufacturer of INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream?

Innovita (Tangshan) Biological Technology Co., Ltd. filed the 510(k) submission for INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream (K192843).

Q: What is the FDA product code for INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream?

LCX. It is classified under 21 CFR 862.1155 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream?

One Step HCG Urine Pregnancy Test (k043443).

Q: Who can help prepare an FDA 510(k) submission like INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K192843 · Innovita (Tangshan) Biological Technology Co., Ltd. · LCX · Nov 22, 2019 · Clinical Chemistry

Device Facts

Record ID	K192843
Device Name	INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
Applicant	Innovita (Tangshan) Biological Technology Co., Ltd.
Product Code	LCX · Clinical Chemistry
Decision Date	Nov 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1155
Device Class	Class 2

Intended Use

The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only.

Device Story

Lateral flow chromatographic immunoassay for qualitative detection of hCG in human urine; detects pregnancy. Device formats: strip, cassette, midstream. Input: urine sample applied to sample pad; hCG binds to colloidal gold-labeled mouse monoclonal anti-beta-hCG antibodies in conjugate pad; complex migrates via lateral flow. Detection: T-line contains immobilized anti-alpha-hCG antibodies capturing complex to form visible pink line; C-line contains immobilized goat anti-mouse IgG capturing excess gold-labeled antibodies to confirm test validity. Used in home/OTC setting by lay users. Results interpreted visually by user; positive result indicates presence of hCG. Benefits: provides rapid, accessible, early pregnancy determination.

Clinical Evidence

Bench testing included precision/sensitivity (25mIU/mL), cross-reactivity (LH, FSH, TSH), interference (endogenous/exogenous compounds), pH, specific gravity, and hook effect (up to 2000IU/mL). Method comparison study (n=300) against predicate showed 100% agreement. Lay user study (n=300) across three sites with diverse demographics demonstrated 100% agreement between lay user results and professional interpretation of the predicate device. Questionnaire confirmed ease of use and instruction clarity; Flesch-Kincaid reading level is 7th grade.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: membrane coated with mouse monoclonal anti-alpha-hCG antibodies; conjugate pad with colloidal gold-labeled mouse monoclonal anti-beta-hCG antibodies; control line with goat anti-mouse IgG. Formats: strip, cassette, midstream. Sensitivity: 25mIU/mL. Storage: 4–30°C. Shelf-life: 3 years. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Intended for Over-the-Counter, in vitro diagnostic use by lay users.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

One Step HCG Urine Pregnancy Test (k043443)

Related Devices

K150063 — One Step hCG Pregnancy Test · Coretests, Inc. · Oct 2, 2015
K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette · Assure Tech., LLC · Feb 13, 2025
K172627 — David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette · Runbio Biotech Co.,Ltd · Mar 28, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products. November 22, 2019 Innovita (Tangshan) Biological Technology Co., Ltd % Fiona Wang Official Correspondent Huajian US Services 19800 MacArthur Blvd, Ste 420 Irvine, CA 92612 Re: k192843 Trade/Device Name: INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 30, 2019 Received: October 3, 2019 Dear Fiona Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality CDRH | Food and Drug Administration Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192843 Device Name INNOVITA HCG Pregnancy Rapid Test Strip INNOVITA HCG Pregnancy Rapid Test Cassette INNOVITA HCG Pregnancy Rapid Test Mistream #### Indications for Use (Describe) The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Residential Use (Per CA STD. 110, Solar Disclosure) | <input checked="true" type="checkbox"/> Resale Transaction (Per CA STD. 110, Solar Disclosure) | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # I. SUBMMITTER Applicant Information: Innovita (Tangshan) Biological Technology Co., Ltd. No. 699 Juxin Street, High-tech Industrial Development Zone, Qian'an, 064400, Hebei, China. Phone: +86-10-83681277 Fax: +86-10-83682966 | Contact Person: | Fang (Fiona) Wang USA Agent | |-----------------|--------------------------------| | Email: | fwang@huajianus.com | | | 19800 MacArthur Blvd Ste 420 | | | Irvine, CA 92612 | | Tel: | 949-874-9889 | | Date: | 9/29/2019 | II. DEVICE # Device Name: INNOVITA HCG Pregnancy Rapid Test Strip INNOVITA HCG Pregnancy Rapid Test Cassette INNOVITA HCG Pregnancy Rapid Test Midstream ### Common Name: Pregnancy Test # Regulatory Information: 1. Regulation Classification section: Class II: 21 CFR §862.1155 - Human chorionic gonadotropin (hCG) ### 2. Product Code: LCX - Kit. Test. Pregnancy. Hcg. Over The Counter 3. Panel: Clinical Chemistry (75) # III. PREDICATE DEVICE Predicate device name: One Step HCG Urine Pregnancy Test Predicate 510(k) number: k043443 {4}------------------------------------------------ # A. Device Description INNOVITA HCG Pregnancy Rapid Test will be sold in three different formats: cassette, test strip. and midstream. The test strip and midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format contains one test device, a disposable plastic dropper and a package insert. INNOVITA HCG Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test device contains mouse monoclonal anti-chCG antibody coated membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG. # B. Indications for Use The INNOVITA HCG Pregnancy Rapid Test Strip detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Cassette detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. The INNOVITA HCG Pregnancy Rapid Test Midstream detects human chorionic gonadotropin (hCG) in urine. This test is used to obtain a visual, qualitative result for the determination of pregnancy. It is intended for Over-the-Counter, in vitro diagnostic use only. {5}------------------------------------------------ # C. Device Comparison Chart | Similarities | | | |---------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Parameter | INNOVITA HCG Pregnancy Rapid Test | Wondfo Pregnancy Test (Predicate Device, k043443) | | Indications for Use | Intended for the qualitative detection of hCG in urine to aid in the early detection of pregnancy | Same | | Intended Use | Over-the-Counter | Over-the-Counter, Professional | | Format | Strip, Cassette, Midstream | Same | | Test Principle | Lateral flow chromatographic immunoassay | Same | | Antibodies | Goat, Mouse | Same | | Sensitivity | 25mIU/mL | Same | | Storage Condition | 4 – 30 °C | Same | | Test Time | 3-5 minutes | Same | | | | | Table 11.1 Device comparison chart | | |--|--|--|------------------------------------|--| |--|--|--|------------------------------------|--| # D. Test Principle When hCG containing urine, sample is applied onto the sample pad, it is diffused through the conjugate pad where hCG forms an antigen-antibody complex with colloidal gold-labeled antibodies. Under the lateral flow action, the complex migrates forward along the test. When passing the T line in the testing zone, the complex is captured and immobilized by pre-coated antiahCG antibodies on the T line and form a pink color line. The free Au-anti-BhCG continues to migrate in the testing zone. When passing the C line, the Au-anti-BhCG mouse antibodies is captured and immobilized by goat -anti-mouse IgG antibodies on the C line and form a pink color. When there is no hCG in the sample, only a pink to purple line appear in the C line, indicating the specimen is negative. The pink line in the control region is to show that the applied specimen is adequate and migrates well. It also serves as an internal control standard for the reagent. # E. Performance Data # 1. Analytical Performance # a. Precision/Sensitivity Precision and Sensitivity study was performed by spiking the negative urine with hCG to obtain at concentrations at 0, 12.5, 18.75, 25, 37.5, 50 and 100mIU/mL Thirty replicates were tested with each spiked urine sample. Three (3) different Lots for each test format were used to perform the testing. The result of the precision/sensitivity test at each concentration of hCG is summarized in the following table. The results demonstrated that the analytical sensitivity of the INNOVITA HCG Pregnancy Rapid test is 25mIU/mL. {6}------------------------------------------------ | | Lot 1 | | Lot 2 | | Lot 3 | | |---------------|----------|----------|----------|----------|----------|----------| | Concentration | Positive | Negative | Positive | Negative | Positive | Negative | | 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 | | 12.5mIU/ml | 1 | 29 | 0 | 30 | 0 | 30 | | 18.75mIU/ml | 14 | 16 | 13 | 17 | 14 | 16 | | 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | # Table 11.2 INNOVITA One Step HCG Test Strip results # Table 11.3 INNOVITA One Step HCG Test Cassette results | | Lot 1 | | Lot 2 | | Lot 3 | | |---------------|----------|----------|----------|----------|----------|----------| | Concentration | Positive | Negative | Positive | Negative | Positive | Negative | | 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 | | 12.5mIU/ml | 0 | 30 | 1 | 29 | 1 | 29 | | 18.75mIU/ml | 13 | 17 | 15 | 15 | 14 | 16 | | 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | # Table 11.4 INNOVITA One Step HCG Test Midstream results | | Lot 1 | | Lot 2 | | Lot 3 | | |---------------|----------|----------|----------|----------|----------|----------| | Concentration | Positive | Negative | Positive | Negative | Positive | Negative | | 0mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 | | 12.5mIU/ml | 0 | 30 | 0 | 30 | 0 | 30 | | 18.75mIU/ml | 12 | 18 | 10 | 20 | 14 | 16 | | 25mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 50mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | | 100mIU/ml | 30 | 0 | 30 | 0 | 30 | 0 | {7}------------------------------------------------ ### b. Linearity and Reportable Range This device provides qualitative results only. ### c. Traceability and Stability INNOVITA HCG Pregnancy Rapid Test Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition. Stressed Stability Study and Real-Time Shelf-Life Study were conducted to monitor the integrity of the INNOVITA HCG Pregnancy Rapid Test. Testing results demonstrate that the shelf-life of the test is 3 years when stored at 4°C-30°C in a sealed foil pouch. ### d. Detection Limit See precision section above (F.1.a) # e. Analytical Specificity #### i. Cross Reactivity To evaluate the cross reactivity with similar hormone compounds, negative urine samples and different levels of HCG negative and HCG positive (25mIU/ml and 100mIU/ml) urine were spiked with different levels of hormone LH (250, 500 and 750mIU/ml), FSH (500, 750 and 1000mIU/ml) and TSH (500, 750 and 1000μIU/ml). Five devices from each format were tested with each spiked urine samples. The results summarized below demonstrated no cross-reactivity at 500mIU/ml LH, 1000mIU/ml FSH or 1000μIU/ml TSH. | Hormone | Concentration | HCG | | | |---------|---------------|----------------------------|-----------|------------| | | | 0 mIU/mL Negative Urine | 25 mIU/mL | 100 mIU/mL | | LH | 250 mIU/mL | - (15/15) | + (15/15) | + (15/15) | | LH | 500 mIU/mL | - (15/15) | + (15/15) | + (15/15) | | LH | 750 mIU/mL | - (8/15) | + (15/15) | + (15/15) | | FSH | 500 mIU/mL | - (15/15) | + (15/15) | + (15/15) | | | | 750 mIU/mL | - (15/15) | + (15/15) | | | | 1000 mIU/mL | - (15/15) | + (15/15) | | TSH | 500 mIU/mL | - (15/15) | + (15/15) | + (15/15) | | | | 750 mIU/mL | - (15/15) | + (15/15) | | | | 1000 mIU/mL | - (15/15) | + (15/15) | Table 11.5 Cross-reactivity study of LH, FSH and TSH {8}------------------------------------------------ #### ii. Endogenous / Exogenous Compounds Potential endogenous interferents and drugs commonly found in urine were evaluated their effect on the performance of INNOVITA HCG Pregnancy Rapid test. Negative urine samples and HCG positive (25mIU/ml) urine were spiked with at least 2 levels of the listed interferents. Five devices from each format were tested with each spiked urine samples. Results demonstrated that no interference was observed at the highest concentrations of the following chemicals tested. | Interferents | Highest Concentration tested that demonstrated no interference | |----------------------------|----------------------------------------------------------------| | acetaminophen | 20mg/dL | | acetone | 20mg/dL | | acetylsalicylic acid | 20mg/dL | | albumin | 2000mg/dL | | ampicillin | 5.3mg/dL | | ascorbic acid | 20mg/dL | | atropine | 20mg/dL | | bilirubin | 2mg/dL | | caffeine | 20mg/dL | | cannabinol | 10mg/dL | | gentisic acid | 20mg/dL | | Glucose | 2000mg/dL | | hemoglobin | 250mg/dL | | hydroxybutyric acid | 2000mg/dL | | ibuprofen | 40mg/dL | | L-ephedrine hydrochloride | 20mg/dL | | methadone | 20mg/dL | | morphine | 10mg/dL | | nicotine | 10mg/dL | | phenylpropanolamine | 20mg/dL | | Proephedrine hydrochloride | 20mg/dL | | salicylic acid | 20mg/dL | | tetracycline | 1.5mg/dL | | uric acid | 20mg/dL | | Ethanol | 1% | Table 11.6 Summary of the interference study #### iii. Urine pH To evaluate the effect of urine pH on the INNOVITA HCG Pregnancy Rapid test, negative urine samples and positive urine containing 25mIU/mL of hCG was adjusted for pH values between 4.0 and 9.0. Five devices from each format were {9}------------------------------------------------ tested with each urine sample. Results demonstrated that test results were not affected by urine pH across 4 to 9. | pH | HCG | | |-----|-----------|-----------| | | Negative | Positive | | 4.0 | - (15/15) | + (15/15) | | 5.0 | - (15/15) | + (15/15) | | 6.0 | - (15/15) | + (15/15) | | 7.0 | - (15/15) | + (15/15) | | 8.0 | - (15/15) | + (15/15) | | 9.0 | - (15/15) | + (15/15) | Table 11.7 Results of the urine pH effect study #### iv. Urine Specific Gravity To evaluate the effect of urine specific gravity (S.G.) on the INNOVITA HCG Pregnancy Rapid test, negative urine samples and positive urine samples with different specific gravities (1.000 - 1.010, 1.011 - 1.020 and 1.021 - 1.030) were collected. hCG was spiked into these urine samples to generate positive urine sample containing 25mIU/mL hCG. Five devices from each format were tested with each urine sample. Results demonstrated that test results were not affected by urine specific gravity between 1.003 and 1.030. Table 11.8 Results of the urine SG effect study | SG | HCG | | |-----------------|-----------|-----------| | | Negative | Positive | | 1.003- 1.010 | - (15/15) | + (15/15) | | 1.011- 1.020 | - (15/15) | + (15/15) | | 1.021- 1.030 | - (15/15) | + (15/15) | {10}------------------------------------------------ #### hCG ß-core Fragment V. Presence of hCG ß-core fragment in urine were evaluated their effect on the performance of INNOVITA HCG Pregnancy Rapid test. Negative urine samples and hCG positive (25mIU/ml) urine samples were spiked with hCG-ß core fragment at the concentrations of 0.5umol/L and 1umol/L. Three devices from each format were tested with each spiked urine samples. The results demonstrated that no interference was observed for hCG-ß core fragment concentrations up to l umol/L equivalent to 1000, 000 pmol/L. | HCG-β core fragment | HCG | | |------------------------|-----------|-----------| | | Negative | Positive | | 0.5µmol/L | - (15/15) | + (15/15) | | 1 µmol/L | - (15/15) | + (15/15) | Table 11.9 Results of effect of hCGB-core fragment study #### High Dose Hook Effect vi. High concentrations of hCG in urine were evaluated for their effect on the performance of INNOVITA HCG Pregnancy Rapid test. Negative urine samples were spiked with hCG standard to make samples that contain hCG concentration at 25mIU/mL, 100mIU/mL, 11U/mL, 10IU/mL, 100IU/mL, 150IU/mL, 500IU/mL, 1000IU/mL and 2000IU/mlL. Three devices from each format were tested with each spiked urine samples. The results demonstrated that no hook effect was observed for hCG concentrations up to 2000IU/mL. | hCG concentration | Strip | Cassette | Midstream | |----------------------|-----------|-----------|-----------| | 25 mIU/mL | + (3/3) | + (3/3) | + (3/3) | | 100 mIU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 1 IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 10IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 100 IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 150 IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 500IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 1000IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | | 2000IU/mL | +++ (3/3) | +++ (3/3) | +++ (3/3) | Table 11.10 Results of high dose hook effect study {11}------------------------------------------------ # 2. Comparison Study - a. Method Comparison with Predicate Method Comparison was performed at three sites where 300 fresh urine samples were collected from females with ages ranging from 18 to 49. For each of urine sample, HCP perform one test using the INNOVITA HCG Pregnancy Rapid Test and one test using the One Step Pregnancy Test (predicate). Total 5 HCP were involved in this study. Three lots of devices were used for comparison study. Tests were carried out with the matched test format. Test results obtained are summarized in the table below: # Table 11.11 Summary of the comparison study with the predicate | | | Predicate | | |--------------------------------------------|-------------|-----------|----------| | | | Positive | Negative | | INNOVITA HCG Pregnancy Rapid test | Positive | 153 | 0 | | | Negative | 0 | 147 | | | Total | 153 | 147 | | | % Agreement | 100% | | - b. Matrix Comparison: Not applicable. # 3. Clinical Study - a. Clinical sensitivity: Not applicable. - b. Clinical specificity: Not applicable. - c. Other Clinical Supporting Data: Lay user study was carried out at three sites. Each site recruited females with diverse ethnical and educational backgrounds with ages ranging from 18 to 49. The study subjects followed the package insert instructions and performed the test without any additional assistance. Study subjects were also asked to collect their own urine sample in a urine collection cup. which was used by the healthcare professional to perform the test with matched format of the new device. The results obtained are summarized in the table below: {12}------------------------------------------------ # Table 11.12 Summary of the OTC study | | | Professional | | |----------|----------|--------------|----------| | | | Strip | | | | | Positive | Negative | | Lay user | Positive | 45 | 0 | | | Negative | 0 | 47 | | | | Predicate device professional | | |----------|----------|-------------------------------|----------| | | | Cassette | | | | | Positive | Negative | | | Positive | 51 | 0 | | Lay user | Negative | 0 | 42 | | | | Predicate device professional | | |----------|----------|-------------------------------|----------| | | | Midstream | | | | | Positive | Negative | | Lay user | Positive | 57 | 0 | | | Negative | 0 | 58 | All participants completed a post-study questionnaire Analysis demonstrated the diversity of age, race and educational background of the study participants. The results of the questionnaire also demonstrate that most of participants found INNOVITA HCG Pregnancy Rapid Test easy to use, the instruction easy to understand, and the result easy to interpret. A Flesch-Kincaid reading analysis was also performed on the package insert for each device format for OTC use and shown 7th grade of the reading level. #### CONCLUSIONS F. The submitted information in this premarket notification is complete and supports a substantial equivalence decision