(32 days)
No
The device is a rapid chromatographic immunoassay, which is a chemical-based test, and the summary does not mention any computational analysis or algorithms.
No.
The device is for the qualitative detection of human chorionic gonadotropin to aid in the early detection of pregnancy, not for therapeutic purposes.
Yes
Explanation: The device is described as "for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy," which directly aligns with the definition of a diagnostic device as it detects a condition (pregnancy).
No
The device description clearly states it is a "single cassette device" which is a physical hardware component used for the test. The summary also describes analytical performance studies involving spiked samples and stability studies, which are characteristic of a physical diagnostic test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin in urine or serum". This involves testing samples taken from the human body (in vitro) to provide diagnostic information (aiding in the early detection of pregnancy).
- Device Description: The description confirms it "measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum". This further reinforces that it's analyzing biological samples outside of the body.
- Performance Studies: The performance studies described involve testing urine and serum samples, which are biological specimens.
The definition of an In Vitro Diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. The Innovita HCG Pregnancy Rapid Combo Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).
Product codes
JHI
Device Description
The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals use including professionals at point of care (POC).
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
- Analytical Performance:
a. Precision/Reproducibility/Cut-Off Value: Negative serum or urine specimens from females were spiked with varying HCG concentrations (commercially available and traceable to the 5th WHO international Standard). The spiked samples were measured in 6 replicates each day for 5 days using 3 different lots at three testing sites. Tests were performed by six different operators for each sample concentration. Results showed cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine were verified.
b. Stability: Stable at 4-30 degrees Celsius for 24 months based on the shelf time stability study.
c. Specificity / Cross Reactivity:
- High Dose Effect: Negative urine and serum samples from females were spiked with varying high HCG concentrations from 500 to 2,000,000 mIU/mL. Tested by 3 different lots and 3 different operators. No hook effect was observed.
- Effects of hCG ß-core fragment: Negative and positive samples (5 and 10 mIU/mL HCG in serum; 10 and 20 mIU/mL HCG in urine) were spiked with various concentrations of ß-core fragment HCG (0 to 2x10^6 pmol/L). Tested by 3 different lots and 3 different operators. No interference was observed.
- Effects of glycoprotein LH, FSH and TSH: Negative and positive samples from females (10 and 20 mIU/mL HCG for urine, and 5 and 10 mIU/mL HCG for serum) were spiked with various concentrations of LH, FSH, and TSH. Tested using three different lots by three operators. No interference was observed at LH concentrations up to 500 mIU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL.
d. Interference: Various exogenous compounds were made at 100X concentrate bulk and spiked in both HCG negative (5mIU/mL for serum, 10mIU/mL for urine) and HCG positive (10mIU/mL for serum, 20mIU/mL for urine) samples from women. Each sample was tested using 3 different lots. The study listed highest concentrations tested that did not cause positive or negative interference.
e. Effect of Urine Specific Gravity and Urine pH: Negative and positive urine samples containing 10 and 20 mIU/mL HCG were tested at pH values from 4 to 9 and at specific gravity values ranging from 1.000 to 1.035 using 3 different lots by 3 different operators. Data showed no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035. - Comparison Studies: A method comparison study was performed against the predicate device (K203272).
- Sample Size: 108 urine and 102 serum samples were collected from 210 women (all expecting to be pregnant, early stage at less than 5 weeks) from three testing sites. Ages ranged from 20 to 49 years old.
- Data Source: Samples were randomly collected at various times throughout the day.
- Test Protocol: Samples were tested by different health professionals with the proposed and the predicate devices at each site.
- Key Results: The study result shows 100% agreement for all samples to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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August 2, 2024
INNOVITA (Tangshan) Biological Technology Co., Ltd. % Jenny Xia Director LSI International Inc 504 East Diamond Ave., Suite I Gaithersburg, Maryland 20877
Re: K241919
Trade/Device Name: Innovita HCG Pregnancy Rapid Combo Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: June 28, 2024 Received: July 1, 2024
Dear Jenny Xia:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Innovita HCG Pregnancy Rapid Combo Test
Indications for Use (Describe)
Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K241919
1. Date: | July 30, 2024 |
---|---|
2. Submitter: | INNOVITA (Tangshan) Biological Technology Co., Ltd. |
No. 699 Juxin Street, High-tech Industrial Development | |
Zone, | |
Qian'an, Hebei, 064400, China. | |
3. Contact person: | Jenny Xia |
LSI International Inc. | |
504 East Diamond Ave., Suite I | |
Gaithersburg, MD 20877 | |
Telephone: 301-525-6856 | |
Fax: 301-916-6213 | |
Email: jxia@lsi-consulting.org |
- Innovita HCG Pregnancy Rapid Combo Test 4. Device Name:
Classification: ClassII
| Product
Code | CFR # | Panel |
---|---|---|
JHI | 862.1155, Human chorionic | |
gonadotropin (HCG) test system | Clinical Chemistry |
-
- Predicate Devices:
K203272, Alltest Pregnancy Rapid Combo Test Cassette
- Predicate Devices:
-
- Intended Use
The Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.
- Intended Use
The test is for health care professionals use including professionals at point of care (POC).
-
- Device Description
The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.
- Device Description
-
- Substantial Equivalence Information
4
summary comparison of features of the Innovita HCG Pregnancy Rapid Combo Test and the predicate device is provided in the following table.
Item | Device | Predicate |
---|---|---|
Intended Use | Rapid qualitative detection of | |
HCG to aid in the early detection | ||
of pregnancy. | Same | |
Specimen | Urine or serum | Same |
Principle | Lateral flow Sandwich | |
Immunochromatographic Assay | Same | |
Detection reagent | Colloidal gold | Same |
Read time | 5 minutes for both serum and urine | Serum: 5 minutes |
Urine: 3 minutes | ||
Usage | For prescription use | Same |
Cut-Off Values | 10 mIU/mL for serum and 20 | |
mIU/mL for urine | Same | |
Configurations | Cassette | Same |
Storage | 4 - 30°C | 2 - 30°C |
9. Test Principle
The kit is a double antibody sandwich immunochromatographic assay that detects the presence of HCG in human serum or urine specimens. Anti ß-HCG antibodies conjugated with colloidal gold is deposited on the conjugate pad, and Anti α-HCG antibodies are immobilized on the test line of the nitrocellulose membrane. When the specimen is applied, the gold-antibody conjugate is rehydrated and the HCG, if there is sufficient HCG in the specimen, interacts with the gold-conjugated antibodies. The antigen-antibody-gold complex then migrates towards the test window until the Test Zone (T) where it gets captured by immobilized antibodies, forming a visible redpurple line (Test line), indicating a positive result. If HCG is absent from the specimen, no red-purple line will be visible in the Test Zone (T), indicating a negative result.
To serve as an internal process control line should always appear at Control Zone (C) after the test is completed. Absence of a red-purple control line in the Control Zone(C) indicates an invalid result.
10. Performance Characteristics
Analytical Performance
a. Precision/Reproducibility/Cut-Off Value
Negative serum or urine specimens from females were spiked with varying HCG (commercially available and traceable to the 5th WHO international Standard)
5
concentrations. The spiked samples were measured in 6 replicates each day for 5 days using 3 different lots at three testing sites. Tests were performed by six different operators for each sample concentration. Results are shown in the following tables.
Serum | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
HCG | ||||||||||
Concentration | ||||||||||
(mIU/mL) | Site 1 | |||||||||
Lot 1 | Site 2 | |||||||||
Lot 2 | Site 3 | |||||||||
Lot 3 | Total | |||||||||
result | % | |||||||||
Negative | % | |||||||||
Positive | ||||||||||
- | + | - | + | - | + | - | + | |||
0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
2.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
7.5 | 13 | 17 | 14 | 16 | 15 | 15 | 42 | 48 | 46.7 | 53.3 |
10 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
12.5 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
15 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Urine | ||||||||||
HCG | ||||||||||
Concentration | ||||||||||
(mIU/mL) | Site 1 | |||||||||
Lot 1 | Site 2 | |||||||||
Lot 2 | Site 3 | |||||||||
Lot 3 | Total | |||||||||
result | % | |||||||||
Negative | % | |||||||||
Positive | ||||||||||
- | + | - | + | - | + | - | + | |||
0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
10 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
12.5 | 23 | 7 | 24 | 6 | 24 | 6 | 71 | 19 | 78.9 | 21.1 |
15 | 14 | 16 | 14 | 16 | 13 | 17 | 41 | 49 | 45.6 | 54.4 |
17.5 | 6 | 24 | 7 | 23 | 5 | 25 | 18 | 72 | 20 | 80 |
20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are verified.
b. Stability Stable at 4-30℃ for 24 months based on the shelf time stability study.
c. Specificity / Cross Reactivity
High Dose Effect
Negative urine and serum samples from females were spiked with varying high HCG concentrations ranging from 500 to 2,000,000 mIU/mL. The spiked samples were
6
tested by 3 different lots and 3 different operators. No hook effect was observed at these concentrations.
Effects of hCG ß-core fragment
Negative and positive samples (5 and 10 mIU/mL HCG in serum; 10 and 20 mIU/mL HCG in urine) were spiked with various concentrations of ß -core fragment HCG (0 to 2x106pmol/L). These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. No interference was observed for these samples with 2x106 pmol/L 3-core fragment hCG for the devices.
Effects of glycoprotein LH, FSH and TSH
Negative and positive samples from females (10 and 20 mIU/mL HCG for urine, and 5 and 10 mIU/mL HCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. No interference was observed for these samples for the device at LH concentrations up to 500 mIU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL.
d. Interference
To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both HCG negative (5mIU/mL for serum, 10mIU/mL for urine) and HCG positive (10mIU/mL for serum, 20mIU/mL for urine) samples. All urine and serum samples were taken from women. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table which lists the highest concentration tested that did not cause positive or negative interference in either serum or urine samples.
Interferents | Concentration |
---|---|
Acetaminophen | 20 mg/dL |
Acetoacetic Acid | 2000 mg/dL |
Ascorbic Acid | 20 mg/dL |
Atropine | 20 mg/dL |
Acetylsalicylic acid | 20 mg/dL |
Albumin | 2000mg/dL |
Bilirubin | 40mg/dL |
Caffeine | 20 mg/dL |
Codeine | 20mg/dL |
Ephedrine | 20 mg/dL |
EDTA | 80 mg/dL |
Ethanol | 1% |
Gentisic Acid | 20 mg/dL |
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Glucose | 2000mg/dL |
---|---|
Hemoglobin | 2000mg/dL |
Methadone | 20mg/dL |
Phenylpropanolamine | 20 mg/dL |
Phenothiazine | 20 mg/dL |
Pregnanediol | 2 mg/dL |
Salicylic Acid | 20 mg/dL |
B-hydroxybutyrate | 2000mg/dL |
Benzoylecgonine | 10mg/dL |
Cannabinol | 10mg/dL |
Methanol | 10% |
Estriol-17-beta | 2mg/dL |
Thiophene | 20mg/dL |
Ampicillin | 20mg/dL |
Tetracycline | 20mg/dL |
Ketone | 20mg/dL |
Uric Acid | 20 mg/dL |
High-density lipoprotein | |
(serum only) | 70mg/dL |
Triglycerides | |
(serum only) | 1200mg/dL |
Total cholesterol | |
(serum only) | 250mg/dL |
e. Effect of Urine Specific Gravity and Urine pH
Negative and positive urine samples containing 10 and 20 mIU/mL HCG were tested at pH values from 4 to 9 and at specific gravity values ranging from 1.000 to 1.035 using 3 different lots by 3 different operators. Data show that there is no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035 of tested urine samples.
f. Comparison Studies
A method comparison study was performed, comparing the results obtained from the Innovita HCG Pregnancy Rapid Combo Test to the results from predicate devices (K203272). 108 urine and 102 serum samples were collected from 210 women (all of these women expect themselves to be pregnant, early stage at less than 5 weeks, and have not undergone any at home or in office pregnancy testing before participating in this study) from three testing sites. Samples were randomly collected at various times throughout the day. Ages ranged from 20 to 49 years old. Samples were tested by different health professionals with the proposed and the predicate devices at each site. The obtained results are shown in the following tables.
Summary Results for Urine Cassette
Predicate device | + | - | |
---|---|---|---|
New Device | + | 52 | 0 |
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- | 0 | 56 | |
---|---|---|---|
-- | --- | --- | ---- |
Summary Results for Serum Cassette
New Device | Predicate device | + | - |
---|---|---|---|
+ | 47 | 0 | |
- | 0 | 55 |
The study result shows 100% agreement for all samples to the predicate device.
g.Clinical Studies
Not applicable
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, interference, specificity and method comparison of the devices, it's concluded that Innovita HCG Pregnancy Rapid Combo Test is substantially equivalent to the predicate.