Who is the manufacturer of iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

Shenzhen Yhlo Biotech Co., Ltd. filed the 510(k) submission for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690).

What is the FDA product code for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

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

What is the regulatory pathway for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

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

What are the predicate devices for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

Elecsys Hcg And Beta Test System (K003178); cobas e 801 Immunoassay analyzer (K162606).

Who can help prepare an FDA 510(k) submission like iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

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.

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

K223690 · Shenzhen Yhlo Biotech Co., Ltd. · DHA · Dec 11, 2023 · Clinical Chemistry

Device Facts

Record ID	K223690
Device Name	iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Applicant	Shenzhen Yhlo Biotech Co., Ltd.
Product Code	DHA · Clinical Chemistry
Decision Date	Dec 11, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1155
Device Class	Class 2

Intended Use

iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG β-subunit (β-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. 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 reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

Device Story

iFlash-HCG is a quantitative sandwich chemiluminescent immunoassay (CLIA) for human serum/plasma; utilizes anti-HCG antibody-coated paramagnetic microparticles and acridinium-ester-labeled anti-HCG antibody conjugate. Sample hCG forms a sandwich complex with reagents; magnetic separation removes unbound materials; pre-trigger and trigger solutions initiate chemiluminescent reaction. iFlash 3000-C analyzer measures resulting relative light units (RLUs) via optical system; concentration derived from 3-point calibration curve and master curve (QR code). Used in clinical laboratories by professionals; results aid clinical decision-making for pregnancy detection. System includes sample loading, incubation, magnetic separation, and photon detection modules. Barcode reader identifies specimens; automated dilution (1:50 or 1:100) available for high-concentration samples.

Clinical Evidence

Bench testing only. Performance validated via precision (CLSI EP05-A3), linearity (CLSI EP06-Ed2), interference (CLSI EP7-A2), and detection limits (CLSI EP17-A2). Method comparison study (n=110) against predicate showed high correlation (R²=0.9980, slope=0.9860). Matrix comparison (n=97) confirmed suitability of serum, lithium heparin, sodium heparin, and K2-EDTA plasma. No clinical sensitivity/specificity studies performed.

Technological Characteristics

Sandwich immunoassay; paramagnetic microparticles; acridinium-ester label; chemiluminescent detection. Fully automated analyzer (iFlash 3000-C) with incubation, magnetic separation, and photon detection. Reagents contain ProClin 300 preservative. Connectivity via barcode reader; calibration via QR code. Standards: CLSI EP05-A3, EP06, EP07, EP37, EP17-A2, EP09c, EP34, EP28-A3c.

Indications for Use

Indicated for laboratory professionals to aid in early pregnancy detection via quantitative measurement of intact hCG and hCG ß-subunit in human serum and plasma.

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

Elecsys Hcg And Beta Test System (K003178)
cobas e 801 Immunoassay analyzer (K162606)

Related Devices

K131037 — LIAISON XL HCG · DiaSorin, Inc. · Sep 6, 2013
K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i System · Abbott Laboratories · Oct 23, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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). {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 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 {2}------------------------------------------------ {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) k223690 ### Device Name iFlash-HCG Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) ### Indications for Use (Describe) 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. | 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) ### 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 Druq 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "YHLO" in a teal color. The letters are large and bold, and the font is sans-serif. The "H" has a curved extension on the left side, which gives the word a unique look. The background is white. # 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 QIAN Email: ra@szyhlo.com Address: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, Shenzhen, Guangdong, 518116, China Phone: 86-755-26609335 | | Date prepared | Dec 9th, 2023 | | Device name | iFlash-HCG Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | | Classification | Product code:DHA, JJE CFR#: 862.1155, 862.2160 Device 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 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). ### 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. {5}------------------------------------------------ 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. 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. # Technological Characteristics Comparison | Feature | Candidate Assay iFlash-HCG k223690 | Predicate Assay Elecsys HCG+ β reagent k003178 | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | Intended use | For quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG β-subunit (β-hCG) in human serum and plasma; used by laboratory professionals as an aid in early detection of pregnancy | Same | | Principle | Sandwich principle. | Same | | Sample Matrix | Human serum, plasma | Same | | Traceability | WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364 | 4th International Standard (NIBSC) code 75/589 | | Calibrator | three-level Calibrator | 2 levels | | Assay range/measuring range | 0.5-10000 mIU/mL | 0.2 – 10000 mIU/mL | | Method Comparison | 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 of analytes in human body fluids. | Same | | Detection Method | Chemiluminescence using magnetic particle solid phase | Electrochemiluminescence | | Automated | Yes | Same | | Calibration | Utilizes a stored calibration curve | Same | {6}------------------------------------------------ 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "YHLO" in a stylized, sans-serif font. The letters are a teal color, and the word is presented in a slightly italicized or slanted manner. The overall design is simple and modern, with a focus on the typography. # 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: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for YHLO, which is a medical device company. The logo is in a teal color and features the company's name in a stylized font. The letters are bold and have a modern look. The logo is simple and clean, making it easily recognizable. 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 | | Tetracycline hydrochloride | 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 {9}------------------------------------------------ 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 premenopausal women (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 {10}------------------------------------------------ Image /page/10/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 connected to each other, and the "H" has a curved line extending from the top. The logo is simple and modern. 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.