Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

K212221 · Diazyme Laboratories, Inc. · DHA · Dec 13, 2021 · Clinical Chemistry

Device Facts

• Record ID: K212221
• Device Name: Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
• Applicant: Diazyme Laboratories, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Diazyme DZ-Lite iFlash Total βhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotropin (total βhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.

Device Story

The Diazyme DZ-Lite iFlash Total βhCG Assay is a sandwich chemiluminescent immunoassay performed on the Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. The system uses anti-HCG coated paramagnetic microparticles and anti-HCG acridinium-ester-labeled conjugate to form a sandwich complex with HCG in human serum. After magnetic separation and washing, trigger solutions are added to initiate a chemiluminescent reaction. The resulting relative light units (RLUs) are measured by the analyzer's optical system. The analyzer is a microcomputer-controlled, random-access instrument that automates sample identification via barcode, aspiration, incubation, and detection. Results are calculated using a 3-point calibration curve and a master curve provided via reagent QR code. The device is intended for clinical laboratory use to aid in pregnancy detection. It provides quantitative results that assist healthcare providers in confirming pregnancy status.

Clinical Evidence

Bench testing only. Analytical performance validated per CLSI guidelines (EP05-A3, EP06-A, EP07-A2, EP17-A2, EP28-A3c). Precision studies (N=240 per analyzer) showed total CV% ranging from 2.3% to 12.1%. Linearity confirmed across 0.6–10,000 mIU/mL. LoQ determined at 0.60 mIU/mL. Method comparison with predicate (N=141) yielded a slope of 0.9976 and R² of 0.9936. No high-dose hook effect up to 1,000,000 mIU/mL. No significant interference from common endogenous substances.

Technological Characteristics

Sandwich immunoassay using paramagnetic microparticles and acridinium-ester-labeled conjugate. Chemiluminescent detection system. Microcomputer-controlled, random-access analyzer. Connectivity via barcode reader for sample identification. Reagents include ProClin 300 preservative. Traceable to WHO 5th International Standard 07/364. Software-controlled automated processing.

Indications for Use

Indicated for the quantitative determination of total βhCG in human serum to aid in the early detection of pregnancy.

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.

Submission Summary (Full Text)

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December 13, 2021

Diazyme Laboratories Inc. Chao Dou Director, R and D 12889 Gregg Court Poway, California 92064

Re: K212221

Trade/Device Name: Diazyme DZ-Lite iFlash Total BhCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: DHA, JJE Dated: August 12, 2021 Received: August 13, 2021

Dear Chao Dou:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiologial Health

Enclosure

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# Indications for Use

510(k) Number (if known) k212221

#### Device Name

Diazyme DZ-Lite iFlash Total ßhCG Assay Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer

#### Indications for Use (Describe)

Diazyme DZ-Lite iFlash Total BhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotro pin (total BhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.

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

| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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