Hematology · 510(k) · 2018
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.. Cleared by FDA on 16 November 2018 under submission K180343, product code POV (semen analysis device). What FDA's record says, in FDA's words.
Device record · K180343
- Device. LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerDEVICE
- Company. Bonraybio Co., Ltd. (TW)COMPANY
- Decision. 16 November 2018, 510(k), substantially equivalent (traditional review); received 7 February 2018DECISION
- Panel. HematologyPANEL
- Product code. POV, Semen Analysis DeviceCODE
- Regulation. 21 CFR 864.5220, Class IIREG
- Source. FDA database entry · decision document (12 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.
LensHooke X1 Semen Quality Analyzer for OTC use The LensHooke X1 Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: -Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value The LensHooke X1 Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status. It is a self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared. LensHooke X1 PRO Semen Quality Analyzer for prescription use The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (10^6 per ml) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke X1 PRO Semen Quality Analyzer 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 healthcare professional setting 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.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsprescription use
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 2018. 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.