Hematology · 510(k) · 2025
LensHooke X12 PRO Semen Analysis System
Bonraybio Co., LTD.. Cleared by FDA on 9 May 2025 under submission K242388, product code POV (semen analysis device). What FDA's record says, in FDA's words.
Device record · K242388
- Device. LensHooke X12 PRO Semen Analysis SystemDEVICE
- Company. Bonraybio Co., LTD. (TW)COMPANY
- Decision. 9 May 2025, 510(k), substantially equivalent (traditional review); received 12 August 2024DECISION
- Panel. HematologyPANEL
- Product code. POV, Semen Analysis DeviceCODE
- Regulation. 21 CFR 864.5220, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) • Progressive Motility (PR, %) (3) Sperm Morphology (normal forms, %) The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR Assay) is an optical device for human semen analysis which provides direct measurement for: (1) Sperm DNA Fragmentation Index (DFI, %) The LensHooke X12 PRO Semen Analysis System does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in clinical laboratories to evaluate male fertility.
The product code's definition, from FDA's classification record. Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code POV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
17 September 2020 · Malfunction · HALOTECH G2 KIT · HALOTECH, SRL. / HALOTECH DNA SL · report MW5096746
INCORRECT FERTILITY TMT; NOT AN INCIDENT BUT A VIOLATION: (B)(4), IS THE IMPORTER OF THE HALOTECH LINE OF SPERM TESTING KITS AND STAINS WHICH ARE WIDELY DISTRIBUTED IN THE US WITH MARKETING CLAIMS REGARDING DNA FRAGMENTATION THAT HAVE NEVER BEEN VALIDATED IN HUMAN CLINICAL TRIALS AND ARE NOT REVIEWED BY THE FDA AS A DIAGNOSTIC TEST. THE SAFETY AND EFFICACY AS WELL AS THERMAL STABILITY OF THE TESTS ARE UNKNOWN, YET THESE TESTS ARE MARKETED WIDELY TO THE IVF AND ART COMMUNITIES OF HEALTHCARE […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code POV, in Hematology, from Bonraybio Co., LTD., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.