Ophthalmic · De Novo · 2018
IDx-DR
IDx, LLC. Granted by FDA on 11 April 2018 under submission DEN180001, product code PIB (diabetic retinopathy detection device). What FDA's record says, in FDA's words.
Device record · DEN180001
- Device. IDx-DRDEVICE
- Company. IDx, LLCCOMPANY
- Decision. 11 April 2018, De NovoDECISION
- Panel. OphthalmicPANEL
- Product code. PIB, Diabetic Retinopathy Detection DeviceCODE
- Regulation. 21 CFR 886.1100, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
must be provided, including the following: a. Clinical performance testing must evaluate sensitivity, specificity, positive predictive value, and negative predictive value for each endpoint reported for the indicated disease or condition across the range of available device outcomes. De Novo Summary (DEN180001) b. Clinical performance testing must evaluate performance under anticipated conditions of use. c. Statistical methods must include the following:
The product code's definition, from FDA's classification record. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
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.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PIB. 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:
22 January 2025 · Injury · AEYE-DS RETINA SCREENING · AEYE HEALTH INC. · report MW5165159
I WITNESSED THE AEYE-DS SAMD SOFTWARE DIAGNOSE A PATIENTS RETINA IMAGE LEVERING IT'S AI(ARTIFICIAL INTELLIGENCE) TECHNOLOGY AND FAIL TO PROVIDE A COMPLETE DIAGNOSIS OF ISSUES PERTAINING TO THE PATIENT'S EYES. THE PATIENT HAD RETINA CONDITIONS THAT WOULD REQUIRE MEDICAL EVALUATIONS BASED ON RETINA CUPPING AND GLAUCOMA WITHOUT HAVING DIABETIC RETINOPATHY AND THE AEYE-DS SYSTEM DID NOT INFORM THE PATIENT OF THIS CONDITION OR REFER THE PATIENT TO ANOTHER SPECIALIST. IT ONLY STATED, "NEGATIVE FOR […]
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 PIB, in Ophthalmic, or granted 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.