Neurology · De Novo · 2021
Cognoa ASD Diagnosis Aid
Cognoa, Inc.. Granted by FDA on 2 June 2021 under submission DEN200069, product code QPF (pediatric autism spectrum disorder diagnosis aid). What FDA's record says, in FDA's words.
Device record · DEN200069
- Device. Cognoa ASD Diagnosis AidDEVICE
- Company. Cognoa, Inc.COMPANY
- Decision. 2 June 2021, De NovoDECISION
- Panel. NeurologyPANEL
- Product code. QPF, Pediatric Autism Spectrum Disorder Diagnosis AidCODE
- Regulation. 21 CFR 882.1491, Class IIREG
- Source. FDA database entry · decision document (10 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.
, precautions and warnings in the HCP Portal Instructions for Use; (2) ensure access to the patient dashboard for viewing patient data, labeling, and HCP Portal log- out; (3) ensure completion of the patient questionnaire; and (4) to ensure the patient’s results can be viewed and querying how the HCP interpreted the results provided for each available device output (Positive for ASD, Negative for ASD, No Result). A test moderator facilitated the testing, provided information regarding the test procedures beforehand, and asked questions specific to each use scenario evaluated. Specific to scenarios testing the use and interpretation of the device outputs, participants were asked to access patient records, discuss their clinical interpretation of each device output, and discuss how they would proceed with clinical decision making, both in the event that the device output affirmed or differed from how the patient presented clinically. Following completion of testing, post-evaluation interviews were conducted using 10 open-ended, neutrally worded questions to evaluate clinical end user perspectives of any use difficulties experienced during the testing. Study results indicated that participants were able to complete identified critical tasks associated with use of the device. All participants understood and were able to navigate the labeling and recite or affirm understanding of the content. All participants were able to access patient records, complete the questionnaire and […]
The product code's definition, from FDA's classification record. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
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 0 reports filed against devices carrying product code QPF. 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.
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 QPF, in Neurology, from Cognoa, Inc., or granted in 2021. 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.