LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

K180343

Bonraybio Co., Ltd. · cleared 2018-11-16 · product code POV · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.”
Algorithmartificial intelligence image processing method" that uses "algorithms for the assessment of semen parameters" to analyze sperm concentration (unit density), motility (tracing sperm trajectories), and morphology (comparing head and tail percentage), and pH (image saturation and brightness analysis).
source quote (p.5)
“Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (8)

Bench

n=60 other

endpoints: CV (%) pH; CV (%) Concentration; CV (%) Motility; CV (%) morphology

Bench

sample size not stated · 3 site(s)

endpoints: CV (%) pH; CV (%) Concentration; CV (%) Motility; CV (%) morphology

Bench

sample size not stated

endpoints: Semen linear regression (slope, R^2); pH linear regression

Bench

sample size not stated

endpoints: meet CLSI: EP7-A2 acceptance criteria for therapeutic levels of concentration

standards: CLSI: EP7-A2

Bench

sample size not stated

endpoints: CV within 5%; bias within 20% for semen concentration; CV within 10%; bias within 10% for pH

Bench

sample size not stated

endpoints: basis within 10%

Bench

sample size not stated

endpoints: stable test cassette strip performance for 8 months under accelerated 40°C condition; estimate shelf life of test strips for 2 years at room temperature

Reader study (MRMC)

n=106 patients

endpoints: layperson user accuracy and ease of use (via participant questionnaire scoring) of Candidate device

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

2
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242830 (decision 2025-05-30) from Bonraybio Co., LTD. for a matching device line ("LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242830

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K202089 (decision 2020-10-28) from Bonraybio Co., Ltd. for a matching device line ("LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K202089

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Hematology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K180343