iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG ß-subunit (ß-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods.

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

Device Description

iFlash-HCG that includes testing reagents and three levels of calibrators is based on chemiluminescence immunoassay. HCG and hCG ß-subunit (ß-hCG) in the sample reacts with anti-HCG antibody coated paramagnetic microparticles and acridinium-labeled anti-HCG antibody conjugate to form a sandwich complex, after chemiluminescent reaction, HCG amount in the sample is derived from RLUs (relative light units) using a calibration curve. iFlash-HCG is intended to be used on Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C).

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

AI/ML Overview

The provided text describes the performance of the iFlash-HCG and Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) for the quantitative detection of human chorionic gonadotropin (hCG). However, it does not detail acceptance criteria in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in terms of clinical performance against defined benchmarks with human experts, as would be typical for an AI/ML-based diagnostic device where acceptance criteria often relate to sensitivity, specificity, and agreement with ground truth.

Instead, the document focuses on detailed non-clinical performance studies demonstrating the analytical characteristics and substantial equivalence to a predicate device. Many of the listed studies (e.g., precision, detection capability, linearity, interference, analytical specificity, method comparison, stability, trueness, sample dilution, reference interval, carryover) are standard for in vitro diagnostic (IVD) devices.

Given the input, I will interpret "acceptance criteria" as the performance specifications demonstrated by the non-clinical studies and "study that proves the device meets the acceptance criteria" as the results of these non-clinical studies. I will also clarify that this is not an AI/ML device per se, so the typical AI/ML study components (experts for ground truth, MRMC, standalone algorithm performance) are not applicable in their traditional sense.

Here's the information extracted and structured based on your request, with caveats where the information is not present or not applicable to an IVD device of this type:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not provide a pre-defined table of "acceptance criteria" in the sense of pass/fail thresholds for clinical performance but rather lists the results of various analytical performance studies, I will present the key performance parameters and their achieved values. The "acceptance criteria" here are implicitly met if the reported performance is deemed suitable for the intended use and demonstrates substantial equivalence to predicate devices.

Performance Parameter	Acceptance Criteria (Implicit / Demonstrated Performance)	Reported Device Performance (as presented)
Precision	Demonstrated according to CLSI EP05-A3 standard	Repeatability and Reproducibility SD and CV% calculated per EP05-A3. (Specific values not provided in summary, but stated to demonstrate fulfillment).
Detection Limit (LoB)	Determined according to CLSI EP17-A2	LoB = 0.10 mIU/mL
Detection Limit (LoD)	Determined according to CLSI EP17-A2	LoD = 0.20 mIU/mL
Detection Limit (LoQ)	Determined according to CLSI EP17-A2	LoQ = 0.50 mIU/mL (Total error limit ≤30%)
Linearity Range	Demonstrated according to CLSI EP06 2nd Edition	0.50 - 10000.00 mIU/mL (predefined allowable deviation ±15%)
Hook Effect	No Hook effect observed within concentration	No HOOK effect observed within HCG/ß-HCG concentration of 1,250,000 mIU/mL.
Interference (Endogenous)	Not susceptible to interference at specified levels	Not susceptible at levels: Bilirubin (conj. ≤40mg/dL, unconj. ≤40mg/dL), Hemoglobin (≤1000mg/dL), Triglyceride (≤3000 mg/dL), Serum total protein (≤10 g/dL), Rheumatoid factors (2000 IU/mL), HAMA (600 ng/mL), ANA (500 AU/mL).
Interference (Exogenous/Drug)	Not susceptible to interference at specified levels	Not susceptible at specified levels for 17 common drugs.
Analytical Specificity (Cross-reactivity)	Not susceptible to interference from specified cross-reactants	Not susceptible to LH (500 mIU/mL), FSH (200 mIU/mL), TSH (10000 mIU/mL).
Specimen Types Comparison	Good agreement between serum and plasma samples	Paired serum and plasma samples in good agreement (Passing-Bablok Regression).
Method Comparison	Good consistency with predicate device	Y=0.986X-0.047; correlation coefficient T= 0.998 (110 serum samples covering 0.531-9717 mIU/mL).
Stability	Data supports claims in user manual	Stability data supports claims.
Trueness	Relative deviation within ±10.0%	Achieved for 25.00, 200.00, 4000.00 mIU/mL samples against WHO standard.
Sample Dilution Recovery	Relative deviation within ±10%	Supports dilution of samples with HCG concentrations above 10000 mIU/mL with max 1:100 dilution.
Reference Interval	Established through study	Non-pregnant premenopausal women (18-50): 95th percentile 0.6 mIU/mL (N=130); Postmenopausal women (≥50): 95th percentile 5.4 mIU/mL (N=125).
Carryover Effect	No carryover effect observed	No carryover effect observed with high HCG (≥1,000,000 mIU/mL) followed by low HCG (≤5 mIU/mL).

2. Sample Size Used for the Test Set and Data Provenance

Test Set (for performance studies):
- Precision: 9 levels of female serum samples and 2 levels of controls (total samples tested over 20 days: 9 samples * 2 runs * 2 replicates * 20 days * 3 lots * 3 analyzers = substantial, specific number of unique patients/samples not given).
- Detection Limit (LoB): 5 analyte-free samples * 4 times/day * 3 days * 3 reagent lots (60 results per reagent lot).
- Detection Limit (LoD): 5 low-concentration samples * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
- Detection Limit (LoQ): 5 samples near LoD * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
- Linearity: 11 different concentration levels of samples for each of 3 linearity intervals tested on 3 reagent lots.
- Hook Effect: 3 high concentration samples and their serial dilutions.
- Interference Study: Not specified, but likely involved multiple samples spiked with interferents.
- Analytical Specificity: Not specified, but likely involved multiple samples spiked with cross-reactants.
- Specimen Types Study: 97 female serum samples compared with plasma samples.
- Method Comparison: 110 serum samples.
- Trueness Study: Samples formulated from WHO International Standard (3 concentration levels).
- Sample Dilution Fold Study: Samples prepared with HCG positive material (3 theoretical concentrations).
- Reference Interval Study: Non-pregnant premenopausal women (N=130), Postmenopausal women (N=125).
- Carryover Study: Test samples with high HCG in triplicate followed by low HCG in triplicate, for five runs.
Data Provenance: The document does not explicitly state the country of origin for the clinical samples used in these studies. It does indicate that the submitter is based in Shenzhen, Guangdong, China. The studies are described as non-clinical performance studies, often implying controlled laboratory conditions rather than broad population-based data collection. All studies appear to be prospective as they are specifically conducted to evaluate device performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This is an IVD device for quantitative measurement of hCG, not an AI/ML medical image analysis or similar diagnostic device that typically relies on human expert interpretation for "ground truth." The ground truth for this device's performance is established by reference methods, certified reference materials (like WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364), and comparison with legally marketed predicate devices. Therefore, the concept of "experts" establishing conventional ground truth as applied to AI/ML clinical studies is not applicable here.

4. Adjudication Method for the Test Set

As there are no human experts classifying or interpreting data for "ground truth" in the AI/ML sense, there is no adjudication method described or applicable. The determination of results is based on the chemical reaction and optical detection by the automated analyzer, with analytical results compared to established reference values or predicate device results.

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

An MRMC study is relevant for diagnostic devices (often imaging-based or AI-assisted) where human reader performance is a key outcome. This document describes an automated IVD assay, not an imaging device or an AI assistance tool for human readers. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This device is a standalone automated analyzer ("algorithm only" in the sense of the instrument performing the test independently). The entire suite of non-clinical performance studies (precision, detection limits, linearity, interference, method comparison, etc.) constitutes the demonstration of its standalone analytical performance. It does not require human-in-the-loop for its operation or result generation in the same way an AI diagnostic algorithm might.

7. The Type of Ground Truth Used

The "ground truth" for the analytical validation of this IVD device is primarily based on:

Reference materials/standards: Notably, the WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364 is used for trueness studies.
Spiked samples: Known concentrations of analytes or interferents are added to samples to confirm recovery and specificity.
Comparison to predicate devices: The results from the iFlash-HCG are compared against those from the cleared predicate devices (Elecsys HCG+β reagent and Cobas e 801 analyzer) to demonstrate substantial equivalence.
Consensus methods/protocols: CLSI guidelines (EP05-A3, EP17-A2, EP06 2nd Edition, EP07-A3, EP37 1st Edition, EP09c 3rd Edition, EP25-A, EP34 1st Edition, EP28-A3c, H26-A2) provide the "ground truth" for how studies should be designed and how performance metrics should be calculated and interpreted.

8. The Sample Size for the Training Set

This document describes a conventional IVD assay and analyzer, not an AI/ML system that undergoes a distinct "training" phase with a large dataset. Therefore, the concept of a "training set" for an AI/ML algorithm is not applicable in this context. The methodology relies on established chemical and physical principles, not machine learning from data.

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is inherently determined by its design specifications, reagents, and analytical principles, validated through the non-clinical studies.

Summary

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Shenzhen YHLO Biotech Co., LTD. Chungen QIAN Deputy General Manager Building 1, YHLO Biopark, Baolong 2nd Road Baolong Subdistrict, Longgang District Shenzhen, Guangdong 518116 China

Re: K223690

Trade/Device Name: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: DHA, JJE Dated: October 31, 2023 Received: October 31, 2023

Dear Chungen QIAN:

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 OS 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 (OS) 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, Digitally signed by Joseph A. Joseph A. Kotarek -S Date: 2023.12.11 Kotarek -S 16:05:00 -05'00 Joey Kotarek, Ph.D. Toxicology Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K223690

Device Name

iFlash-HCG Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SHENZHEN YHLO BIOTECH CO., L

510(k) Summary

Submitter name	SHENZHEN YHLO BIOTECH CO., LTD
Address	Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict,Longgang District, Shenzhen, Guangdong, 518116, China
Contact person	Name: Chungen QIANEmail: ra@szyhlo.comAddress: Building 1, YHLO Biopark, Baolong 2nd Road, BaolongSubdistrict, Longgang District, Shenzhen, Guangdong, 518116, ChinaPhone: 86-755-26609335
Date prepared	Dec 9th, 2023
Device name	iFlash-HCGChemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Classification	Product code:DHA, JJECFR#: 862.1155, 862.2160Device name:System, Test, Human Chorionic Gonadotropin;Analyzer, Chemistry (Photometric, Discrete) for Clinical Use
Candidate Device	K223690
Predicate Devices	K003178, Elecsys HCG+β reagent;K162606, Cobas e 801 analyzer

Device Description 1

Intended Use 2

iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG ß-subunit (B-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). The iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods.

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Image /page/5/Picture/0 description: The image shows the logo for YHLO, which is a medical device company. The logo is written in a sans-serif font and is a teal color. The letters are bold and slightly slanted to the right. The bottom of the Y extends to the right, underlining the H.

深圳市亚辉龙生物科技股份有限公司 SHENZHEN YHLO BIOTECH CO., LTD.

Technological Characteristics Comparison

Feature	Candidate AssayiFlash-HCGK223690	Predicate AssayElecsys HCG+ β reagentK003178
Intended use	For quantitative detection of the intact humanchorionic gonadotropin (hCG) molecule and thehCG β-subunit (β-hCG) in human serum andplasma; used by laboratory professionals as anaid in early detection of pregnancy	Same
Principle	Sandwich principle.	Same
Sample Matrix	Human serum, plasma	Same
Traceability	WHO International Standard 5th WHO ISChorionic Gonadotrophin 07/364	4th International Standard(NIBSC) code 75/589
Calibrator	three-level Calibrator	2 levels
Assayrange/measuringrange	0.5-10000 mIU/mL	0.2 – 10000 mIU/mL
MethodComparison	Spearman correlation Coefficient (T) = 0.998,Slope = 0.986,y-intercept = -0.047 mIU/mL.	Correlation Coefficient (R) = 1.00,Slope = 0.9455,y-intercept = 0.482

Table 1:Technical Characteristics Comparison Table for the assay

Table 2: Technical Characteristics Comparison Table for the analyzer
----------------------------------------------------------------------	--	--

Feature	Candidate Device	Predicate Device
	Chemiluminescence Immunoassay Analyzer	Cobas e 801 analyzer
	(Model: iFlash 3000-C)	K162606
	K223690
Intended use	For quantitative or qualitative determination ofanalytes in human body fluids.	Same
DetectionMethod	Chemiluminescence using magnetic particlesolid phase	Electrochemiluminescence
Automated	Yes	Same
Calibration	Utilizes a stored calibration curve	Same

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Image /page/6/Picture/0 description: The image shows the logo for Shenzhen YHLO Biotech Co., Ltd. The logo consists of the letters "YHLO" in a stylized, teal-colored font on the left. To the right of the letters is the company's name in both Chinese and English: "深圳市亚辉龙生物科技股份有限公司" and "SHENZHEN YHLO BIOTECH CO., LTD."

Summary of Non-Clinical Performance 3

The non-clinical performance studies that support substantial equivalence are summarized below.

Precision: Repeatability, Reproducibility according to EP05-A3
Detection capability: LoB, LoD, LoQ according to EP17-A2
Linearity according to EP06 2nd Edition ●
Hook Effect
Interference Study according to EP07-A3 and EP37 1st Edition
Analytical Specificity (EP07-A3)
Specimen Types Study
Method Comparison with Predicate Device (EP09c 3rd Edition)
Stability study (EP25-A)
Trueness Study
Sample Dilution Fold Study (EP34 1st Edition)
Reference Interval Study (EP28-A3c) .
Carryover Study
Abovementioned studies demonstrate the fulfillment of performance specifications.
Precision (Repeatability, Reproducibility) 3.1

The experiment is established according to CLSI EP05-A3 protocol, 3 different operators in 3 different laboratories use 3 lots of iFlash-HCG reagent and 3 Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) to conduct the study. For each lot of reagent, the same set of 9 levels of female serum samples with different HCG levels and 2 levels of controls are tested on 3 different Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). The samples and controls are tested with 2 runs per day (at least a two-hour separation between runs), 2 replicates per run for 20 days.

Repeatability and reproducibility precision (SD and CV%) were calculated according to EP05-A3.

3.2 Detection Limit (LoB, LoD, LoQ)
The LoB, LoD, and LoQ study are performed based on EP17-A2 using female serum samples.

LoB is the highest observed measurement value on analyte free samples for 3 lots of reagent kits on one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). For each reagent lot, 5 analyte free samples are tested 4 times per day for 3 consecutive days to record 60 results. Calculation is based on EP17-A2 and LoB is determined to be LoB=0.10 mIU/mL.

LoD is the maximal value of the LoDs obtained for 3 reagent lots on one Chemiluminescence Immunoasay Analyzer (Model: iFlash 3000-C). Each reagent lot tests 5 low-concentration samples (LoB-5LoB) four times a day for 3 consecutive days to obtain 60 test results and calculation are based on EP17-A2. LoD is determined to be LoD = 0.20 mIU/mL.

LoQ is the greatest LoQ across 3 reagent lots on one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). Each reagent lot tests 5 samples with a concentration equal to or slightly greater than LoD, 4 times a day for 3 days in total, and record 60 test

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深圳市亚辉龙生物科技股份有限公司 SHENZHEN YHLO BIOTECH CO., LTD.

results. Total error limit is set as ≤30% and calculation is carried out as per EP17-A2. LoQ is determined to be LoQ= 0.50 mIU/mL.

Linearity 3.3
Linearity study is carried out in accordance with EP06 2nd Edition using female serum samples. Those claimed linearity interval (0.50 mIU/mL-10000.00 mIU/mL), low linearity interval (0.50 mIU/mL-1000.00 mIU/mL) and lower linearity interval (0.50 mIU/mL-100.00 mIU/mL) are studied on 3 reagent lots and on one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). For each interval, 11 different concentration level of samples are obtained by mixing low level serum samples and high level serum samples and each concentration level is calculated for mean value, standard deviation (SD) and coefficient of variation (CV%) with predefined allowable deviation target from linearity as ±15%. Calculation is based on guideline EP06 2nd Edition and linearity is evaluated to be 0.50-10000.00 mIU/mL.
3.4 Hook Effect
3 high concentration samples (sample 1, 750,000 mIU/mL; sample 2, 1,000,000 mIU/mL and sample 3, 1.250.000 mIU/mL) were prepared by adding calibrator high-value positive material into low female serum samples (<0.10 mIU/mL) with subsequent serial dilutions to prepare multiple concentration gradient samples. High-concentration samples 1-3 and diluted samples are tested using 3 different lots of the reagent on one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) with 3 replicates. The obtained results indicate no HOOK effect was observed within HCG/ß-HCG concentration of 1,250,000 mIU/mL.
3.5 Interference Study
Endogenous and exogenous interference study is carried out based on EP07-A3 and EP37 1st Edition using female serum samples. Interference screening testing considers the relative deviation dobs within ±10.0% to have no interference and dose effect test follows if interference exists for a specific substance.

iFlash-HCG is not susceptible to endogenous interference when evaluated at the levels presented in the table below:

Interferent	Concentration
Conjugated bilirubin	≤40mg/dL
Unconjugated bilirubin	≤40mg/dL
hemoglobin	≤1000mg/dL
triglyceride	≤3000 mg/dL
serum total protein	≤10 g/dL
rheumatoid factors	2000 IU/mL
HAMA	600 ng/mL
ANA	500 AU/mL

iFlash-HCG is not susceptible to exogenous interference-drug when evaluated at the levels presented in the table below:

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圳市亚耀龙生物科技股份有限 SHENZHEN YHLO BIOTECH CO., LT

Drug	Concentration
Phenylbutazone	400 µg/mL
Aspirin	1000 µg/mL
Acetaminophen	200 µg/mL
Ibuprofen	500 µg/mL
N-acetylcysteine	150 µg/mL
Methyldopa	25 µg/mL
Theophylline	60 µg/mL
Metformin	12 µg/mL
Isosorbide dinitrate	6 µg/mL
Rifampicin	48 µg/mL
Tetracyclinehydrochloride	24 µg/mL
Cefoxitin	6600 µg/mL
Cyclosporine	2 µg/mL
Metronidazole	125 µg/mL
Ascorbic acid	60 µg/mL
Ampicillin-Na	100 µg/mL
Levodopa	20 µg/mL

Analytical Specificity (Cross-reactivity) 3.6

Cross-reactivity is carried out for potential cross-reactants LH, TSH and FSH using female serum samples based on EP07-A3. The iFlash-HCG is not susceptible to interference from the cross-reactants when evaluated at the levels presented in the table below:

Cross-Reactant	Concentration
LH	500 mIU/mL
FSH	200 mIU/mL
TSH	10000 mIU/mL

3.7 Specimen Types Study (Sample Matrix Comparison)

Values obtained from 97 female serum samples are compared with plasma samples using lithium heparin, sodium heparin and K2-EDTA from the same patient, on 3 reagent lots and one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). For each reagent lot, paired serum and plasma samples are tested once and Passing-Bablok Regression analysis determines that claimed plasma samples are in good agreement with serum samples.

3.8 Method Comparison with Predicate Device
Method comparison is carried out between candidate devices and predicate devices as per EP09c 3rd Edition. 110 serum samples that cover 0.531mIU/mL- 9717mIU/mL (determined by predicate devices) are used during the study and Passing -Bablok regression provides the following regression equation, showing good consistency with the predicate: Y=0.986X-0.047

correlation coefficient T= 0.998

3.9 Stability study

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Image /page/9/Picture/0 description: The image shows the word "YHLO" in a stylized, sans-serif font. The letters are a teal color. The letters are connected to each other, and the "H" has a curved extension on the left side.

深圳市亚辉龙生物科技股份有限公

SHENZHEN YHLO BIOTECH CO., LTD

The stability data supports claims as reported in the user manual.

Trueness study 3.10
The WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364 is formulated into samples with concentration of 25.00 mIU/mL (low-concentration sample), 200.00 mIU/mL (middle-concentration sample) and 4000.00 mIU/mL (high-concentration sample) for testing, on 3 reagent lots and one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)., with testing duplicates 3. For every sample under a reagent lot, relative deviation between the test result and corresponding target value falls within ±10.0%.

Sample Dilution Fold Study 3.11

Studies are performed with both female serum and plasma samples to determine the sample recovery after a 1:50, 1:100 and 1:200 dilutions are performed. 3 theoretical concentration samples at 12000.00 mIU/mL, 400000.00 mIU/mL and 800000.00 mIU/m are prepared by adding HCG positive material to HCG mixed low-value serum, plasma samples. Diluted samples at three dilution ratios are tested for 3 replicates with mean value calculated and multiplied by the dilution fold, which is recorded as the final concentration and compared with the theoretical concentration for relative deviation (within ±10%). Dilution study results support the claim that, samples with HCG concentrations above the measuring range 10000 mIU/mL can be diluted with the maximum dilution ratio 1:100 (either automatically by the analyzer or manually) .

3.12 Reference Interval Study
The reference interval study is performed in accordance CLSI EP28-A3c and obtained results are as follows:

Grouping	Number	95th percentile (mIU/mL)
Non-pregnant premenopausalwomen (age:18-50 years old)	130	0.6
Postmenopausal women (age:≥50 years old)	125	5.4

3.13 Carryover study

Carryover study is performed in accordance with CLSI H26-A2. Test samples with high HCG (≥1,000,000 mIU/mL) in triplicate and followed by low HCG (≤5 mIU/mL) concentrations in triplicate (i.e. H1, H2, H3, L1, L2, L3 as a run) on one Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) for five runs with no carryover effect.

Summary of Clinical Study 4

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深圳市亚辉龙生物科技股份有限公司 SHENZHEN YHLO BIOTECH CO., LTD.

Substantial Equivalence 5

Taking into account technological characteristics, performance specifications that have been fulfilled, and method comparison with predicate device, it is concluded that the candidate device is as safe and effective as predicate device.

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.