LensHooke X12 PRO Semen Analysis System

Bonraybio Co., LTD. • Hematology • 05/09/2025

510(k)IEC 62304 Class B

Device Purpose

The LensHooke X12 PRO Semen Analysis System is an optical in-vitro diagnostic device designed to quantify key sperm parameters, including concentration, motility, morphology, and DNA fragmentation, to assist in male fertility evaluation. Its clearance for marketing is based on its comparability to a predecessor device, highlighting a regulatory pathway for automated semen analysis tools.

Summary

Bonraybio Co., LTD. has developed the LensHooke X12 PRO Semen Analysis System, an optical device designed for human semen analysis. This system provides direct and calculated measurements for sperm concentration, total and progressive motility, and sperm morphology. When utilized with specific test kits, it can also measure the Sperm DNA Fragmentation Index. The system functions as an in-vitro diagnostic tool, intended for use by individuals in clinical laboratories to aid in evaluating male fertility, though it does not offer a comprehensive assessment of fertility status.The LensHooke X12 PRO Semen Analysis System has been reviewed and found to be comparable to a previously available device, the LensHooke X1 PRO Semen Quality Analyzer. This finding permits the device to be marketed, provided it adheres to applicable requirements. These include standards for annual registration, device listing, manufacturing practices, labeling, and prohibitions against misrepresentation. The device is also subject to quality system regulations and requirements for a unique device identifier, in addition to other relevant federal statutes and regulations.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

LensHooke X12 PROSemen Analysis SystemOptical deviceSperm concentrationSperm motilitySperm morphologySperm DNA Fragmentation IndexIn-vitro diagnosticMale fertility evaluationRegulatory compliance

Device Metadata

Submission Number

K242388

Company

Bonraybio Co., LTD.

Panel

Hematology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What is the specific optical methodology employed by the LensHooke X12 PRO to measure sperm parameters?; How do the accuracy and precision of the LensHooke X12 PRO compare to gold-standard manual or other automated semen analysis methods?; What are the clinical implications of the Sperm DNA Fragmentation Index measurement obtained by this device for male fertility prognosis?; What are the specific performance characteristics (e.g., sensitivity, specificity, reproducibility) of the system across different sample qualities?; What training and quality control measures are recommended or required for clinical laboratory personnel using the LensHooke X12 PRO?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score5/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan⚠ Not in summary - likely in full submission per §524B

§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(labeling)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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