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.

Device Description

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

AI/ML Overview

This particular document (K212221) is an FDA 510(k) clearance letter, which formally states that the Diazyme DZ-Lite iFlash Total BhCG Assay and Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer are "substantially equivalent" to legally marketed predicate devices.

This document itself does NOT contain the detailed study information (acceptance criteria, test results, sample sizes, ground truth establishment, etc.) that you are asking for.

Typically, this detailed information would be found in the 510(k) summary document submitted by the manufacturer to the FDA, or in the underlying scientific reports and validation studies that formed the basis for the 510(k) submission. The clearance letter only refers to the submission and acknowledges its review.

Therefore, I cannot provide the specific answers to your detailed questions based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission documents, particularly the "510(k) Summary" and potentially the "Device Description" and "Performance Data" sections.

If you had the 510(k) summary, here's how I would typically extract and present the information you requested (using placeholder text where the information is missing from the current document):

1. A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Accuracy / Correlation with Predicate	[e.g., Correlation coefficient (R) > 0.95; Bias within +/- X%]	[Specific R-value, observed bias]
Precision (Intra-assay CV)	[e.g., CV < 10% for low concentrations, CV < 5% for high concentrations]	[Reported CV ranges for different concentration levels]
Precision (Inter-assay CV)	[e.g., CV < 15% for low concentrations, CV < 8% for high concentrations]	[Reported CV ranges for different concentration levels]
Limit of Detection (LoD)	[e.g., LoD ≤ X mIU/mL]	[Specific LoD value found]
Limit of Quantitation (LoQ)	[e.g., LoQ ≤ Y mIU/mL]	[Specific LoQ value found]
Linearity / Measuring Range	[e.g., Linear range from X to Y mIU/mL with R^2 > 0.99]	[Observed linear range and R^2]
Interference	[No significant interference from common substances (e.g., hemoglobin, lipids, bilirubin, common medications) at specified concentrations]	[Results indicating no significant interference at tested concentrations]
Cross-Reactivity	[No significant cross-reactivity with structurally similar hormones (e.g., LH, FSH, TSH) at specified concentrations]	[Results indicating negligible cross-reactivity]
Prozone Effect	[No prozone effect observed up to Z mIU/mL]	[Results confirming no prozone effect observed up to tested high concentrations]

2. Sample size used for the test set and the data provenance

Sample Size: [e.g., X number of clinical serum samples; Y number of spiked samples]
Data Provenance: [e.g., Retrospective clinical samples collected from hospitals in the United States and Europe; Spiked samples prepared in-house; Prospective clinical samples from a multi-center study in [Country/Region]]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: N/A (For an immunoassay like BhCG, "ground truth" is typically established by reference methods or validated laboratory methods, not expert consensus in the diagnostic imaging sense).
Qualifications of Experts: N/A

4. Adjudication method for the test set

Adjudication Method: N/A (Ground truth for immunoassay is typically based on a gold standard measurement method, not human adjudication of interpretations).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is an in vitro diagnostic (IVD) immunoassay, not an imaging AI device that assists human readers. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes. The performance data presented (e.g., accuracy, precision, LoD, linearity) is the standalone performance of the Diazyme DZ-Lite iFlash Total BhCG Assay on the Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. The device is designed to provide a quantitative result directly.

7. The type of ground truth used

Type of Ground Truth: For the Diazyme DZ-Lite iFlash Total BhCG Assay, the "ground truth" is established through:
- Reference Methods: Comparison of results with a legally marketed predicate device or a clinical laboratory gold standard method (e.g., another highly accurate BhCG assay, often traceably calibrated to the 1st IRP WHO standard).
- External Quality Control Materials: Samples with known concentrations.
- Spiked Samples: Negative samples to which known concentrations of BhCG are added.
- Patient Samples: Clinical samples from various populations (pregnant, non-pregnant, specific medical conditions) with BhCG levels confirmed by reference methods.

8. The sample size for the training set

Training Set Sample Size: This is generally not applicable in the same way it is for AI/machine learning algorithms. For IVD devices, the development involves optimizing reagents and assay parameters through extensive R&D, rather than "training" an algorithm on a distinct dataset. The "training" would be part of the assay development and optimization process, not a separate, quantified "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: N/A (See #8 above). The assay development aims to accurately measure BhCG, and the establishment of its accuracy and other performance characteristics relies on the scientific principles of immunoassay and validation against reference materials and methods.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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.