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).

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.

AI/ML Overview

The provided text describes the performance characteristics of the Innovita HCG Pregnancy Rapid Combo Test, a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (HCG) in urine or serum to aid in early detection of pregnancy.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this device are implicitly tied to its performance characteristics, aiming to demonstrate substantial equivalence to a legally marketed predicate device (K203272, Alltest Pregnancy Rapid Combo Test Cassette). The document doesn't explicitly list "acceptance criteria" as pass/fail thresholds in a formal table, but rather presents the results of various analytical studies that collectively support the device's accuracy, precision, and reliability.

However, based on the performance data presented, here's a table summarizing the implicit criteria and the reported performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Cut-off Values (Sensitivity)	Serum: 10 mIU/mL verified (100% positive at 10 mIU/mL, 46.7% negative at 7.5 mIU/mL transitioned to 53.3% positive). Urine: 20 mIU/mL verified (100% positive at 20 mIU/mL, 45.6% negative at 15 mIU/mL transitioned to 54.4% positive; 20% negative at 17.5 mIU/mL transitioned to 80% positive).
Precision/Reproducibility (across lots, sites, operators)	Serum: At 10 mIU/mL and above, 100% positive across all 3 lots, 3 sites, and 6 operators (total 90 tests each concentration). At 7.5 mIU/mL, 46.7% negative and 53.3% positive results demonstrating transition range. Urine: At 20 mIU/mL and above, 100% positive across all 3 lots, 3 sites, and 6 operators (total 90 tests each concentration). At 15 mIU/mL, 45.6% negative and 54.4% positive results. At 17.5 mIU/mL, 20% negative and 80% positive.
Stability	Stable at 4-30°C for 24 months based on shelf-time stability study.
High Dose Effect (Hook Effect)	No hook effect observed at HCG concentrations ranging from 500 to 2,000,000 mIU/mL.
Specificity / Cross-Reactivity (Interference from related substances)	hCG ß-core fragment: No interference observed with up to 2x10^6 pmol/L. Glycoprotein hormones (LH, FSH, TSH): No interference observed at LH up to 500 mIU/mL, FSH up to 1000 mIU/mL, and TSH up to 1000 µIU/mL.
Interference from Common Exogenous Compounds	No positive or negative interference observed with a wide range of compounds (e.g., Acetaminophen, Caffeine, Alcohol, Glucose, Hemoglobin, various drugs) at specified high concentrations (listed in document).
Effect of Urine Specific Gravity & pH	No interference observed from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035.
Method Comparison (vs. Predicate Device)	Urine Cassette: 100% agreement (52 positive, 56 negative) with the predicate device. Serum Cassette: 100% agreement (47 positive, 55 negative) with the predicate device.

2. Sample Sizes and Data Provenance

Test Set Sample Size:
- Precision/Reproducibility/Cut-Off Value Study: For each HCG concentration, 6 replicates per day for 5 days, using 3 different lots, across 3 testing sites. This totals 90 individual tests per concentration (6 replicates * 5 days * 3 lots = 90). The number of unique samples (negative serum/urine spiked with HCG) is not explicitly stated beyond "Negative serum or urine specimens from females were spiked with varying HCG concentrations."
- High Dose Effect Study: Spiked samples tested by 3 different lots and 3 different operators. The exact number of replicate tests is not specified, but multiple concentrations were tested.
- Effects of hCG ß-core fragment, LH, FSH, TSH interference studies: Samples tested by 3 different lots and 3 different operators. Number of replicates not specified.
- Interference from Common Exogenous Compounds: Each spiked sample tested using 3 different lots; number of replicates per lot not specified.
- Effect of Urine Specific Gravity and Urine pH: Tested using 3 different lots by 3 different operators; number of replicates not specified.
- Method Comparison Study: 108 urine samples and 102 serum samples from 210 women.
Data Provenance:
- No specific country of origin is mentioned for the clinical samples. The submitter is INNOVITA (Tangshan) Biological Technology Co., Ltd. in China, and the contact person is in the USA.
- The method comparison study states: "108 urine and 102 serum samples were collected from 210 women... from three testing sites." The study is described as "A method comparison study was performed," suggesting a prospective collection of samples for the purpose of the study, rather than retrospective. The samples were from "women expecting to be pregnant, early stage at less than 5 weeks."

3. Number of Experts and Qualifications for Ground Truth

The document states that for the Precision/Reproducibility study, tests were performed by six different operators for each sample concentration across three sites, and the interference studies were performed by three different operators.
The "Method Comparison Study" states: "Samples were tested by different health professionals with the proposed and the predicate devices at each site."
Qualifications of these "operators" or "health professionals" are not specified beyond their role in performing the tests. No mention is made of "experts" specifically establishing a ground truth through consensus in the studies described.
The ground truth for the analytical studies (precision, cut-off, interference) was established by the known concentrations of spiked HCG (traceable to the 5th WHO international Standard).
For the comparative study, the "ground truth" was essentially the result of the predicate device (K203272). The study aims to show agreement with the predicate, not necessarily against an independent clinical "true" state confirmed by external means like pathology or clinical outcomes.

4. Adjudication Method for the Test Set

For the analytical studies (precision, cut-off, interference), the "ground truth" was the known spiked concentration of HCG. The "adjudication" was the comparison of the device's result ("-" or "+") against this known concentration. There's no mention of an expert adjudication process in this context, as results are quantitative comparisons to predefined levels.
For the Method Comparison Study, the document states "The study result shows 100% agreement for all samples to the predicate device." This implies a direct comparison of the new device's result to the predicate device's result for each sample. There's no indication of an adjudication method (e.g., 2+1 or 3+1 expert review) for resolving discrepancies, as presumably, there were no discrepancies ("100% agreement").

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study, as typically understood for evaluating AI-assisted workflows in diagnostic imaging, was not performed. This device is a rapid diagnostic test kit, not an AI or imaging device that assists human readers.
The comparison study was between the new device and a predicate device, both read by "different health professionals." The effectiveness is measured by agreement between the devices, not by human reader performance improvement with/without AI assistance.

6. Standalone (Algorithm Only) Performance

This question is not applicable to this device. The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow immunoassay cassette, not a software algorithm or an AI system that would have a "standalone" algorithmic performance. Its performance is intrinsically linked to the physical test kit's chemical reactions and visual interpretation.

7. Type of Ground Truth Used

For the analytical performance studies (precision, cut-off, high dose, specificity, interference, pH/SG): The ground truth was analytical truth based on known, precisely controlled concentrations of HCG (traceable to WHO international standard) and interferents spiked into negative or known positive samples.
For the method comparison study: The ground truth was effectively the results obtained from the legally marketed predicate device (K203272). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. No pathology or long-term clinical outcome data was used as ground truth for this submission.

8. Sample Size for the Training Set

Not applicable / Not explicitly stated. This is a rapid diagnostic test kit, not a machine learning model that typically requires a large "training set" of data. The "training" of such a device is in its chemical and biological design and manufacturing process, not in data-driven algorithmic learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there's no "training set" in the context of an AI/ML device. The "ground truth" for developing and manufacturing such a chemical assay would involve rigorous quality control, calibration, and R&D studies based on established biological and chemical principles, likely using purified HCG standards and clinical samples. However, the document does not detail these developmental processes.

Summary

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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).

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY K241919

1. Date:	July 30, 2024
2. Submitter:	INNOVITA (Tangshan) Biological Technology Co., Ltd.No. 699 Juxin Street, High-tech Industrial DevelopmentZone,Qian'an, Hebei, 064400, China.
3. Contact person:	Jenny XiaLSI International Inc.504 East Diamond Ave., Suite IGaithersburg, MD 20877Telephone: 301-525-6856Fax: 301-916-6213Email: jxia@lsi-consulting.org

Innovita HCG Pregnancy Rapid Combo Test 4. Device Name:
Classification: ClassII

ProductCode	CFR #	Panel
JHI	862.1155, Human chorionicgonadotropin (HCG) test system	Clinical Chemistry

1. Predicate Devices:
  K203272, Alltest Pregnancy Rapid Combo Test Cassette
1. 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.

The test is for health care professionals use including professionals at point of care (POC).

1. 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.
1. Substantial Equivalence Information

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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 ofHCG to aid in the early detectionof pregnancy.	Same
Specimen	Urine or serum	Same
Principle	Lateral flow SandwichImmunochromatographic Assay	Same
Detection reagent	Colloidal gold	Same
Read time	5 minutes for both serum and urine	Serum: 5 minutesUrine: 3 minutes
Usage	For prescription use	Same
Cut-Off Values	10 mIU/mL for serum and 20mIU/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)

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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
HCGConcentration(mIU/mL)	Site 1Lot 1		Site 2Lot 2		Site 3Lot 3		Totalresult		%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
HCGConcentration(mIU/mL)	Site 1Lot 1		Site 2Lot 2		Site 3Lot 3		Totalresult		%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

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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.

Regulation Number and Section

§ 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.