Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor3Product Code
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System2Product Code
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System2Product Code
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System2Product Code
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System2Product Code
- OZOAutomated Insulin Dosing , Threshold Suspend3Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QDJDirect-To-Consumer Access Pharmacogenetic Assessment System2Product Code
- OZPAutomated Insulin Dosing Device System, Single Hormonal Control3Product Code
- LHEController, Closed-Loop Blood Glucose3Product Code
- LKVEnzyme Immunoassay, Fetal Fibronectin3Product Code
- LMYMonitor, Skin Resistance/Skin Temperature, For Insulin Reactions3Product Code
- LTCHyaline Membrane Disease Assay3Product Code
- MDSSensor, Glucose, Invasive3Product Code
- MWQSystem, Test, Total Antioxidant Status3Product Code
- NCTInstrument, Glucose, Noninvasive Technology3Product Code
- NQCTest, Breath Analysis, Volatile Organic CompoundsFProduct Code
- NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNProduct Code
- NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemNProduct Code
- OTVResearch Use Only/Clinical Chemistry DevicesNProduct Code
- OZQAutomated Insulin Dosing Device System, Bihormonal Control3Product Code
- PAQTest, Nr2 AntibodyNProduct Code
- PARTest, Volatile Organic Compounds Breath AnalysisFProduct Code
- PDAInvestigational Use Only - Clinical ChemistryNProduct Code
- PEJSalivary Estriol Test3Product Code
- PHKTest, Cell Mediated Immune Response, Liver And Small Bowel Transplant/TransplantationNProduct Code
- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
- QCDContinuous Glucose Monitor, Implanted, Adjunctive Use3Product Code
- QHJSensor, Glucose, Implanted, Non-Adjunctive Use3Product Code
- QRVSetmelanotide Eligibility Gene Variant Detection System2Product Code
- QWZPrognostic Test For Assessment Of Chronic Kidney Disease Progression2Product Code
- QXCDiabetes Digital Therapeutic Device2Product Code
- SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate2Product Code
- SCHLdt, Approved By Nys ClepNProduct Code
- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCFLdt, Unmet Need Within An Integrated Healthcare SystemNProduct Code
- SCGModified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCIIvd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Direct-To-Consumer Access Pharmacogenetic Assessment System
- Page Type
- Product Code
- Definition
- A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.
- Physical State
- The test system includes reagents and instrumentation for measuring and analyzing nucleic acid sequences and methods for interpretation of the pharmacogenetic associations for detected nucleic acid sequence variations. The test system provides information on the pharmacogenetic associates for the detected variants in lay-user reports.
- Technical Method
- Measures and analyzes nucleic acid sequences and interprets pharmacogenetic associations for detected nucleic acid sequence variations.
- Target Area
- Sample collection device, molecular diagnostic test
- Regulation Medical Specialty
- Medical Genetics
- Review Panel
- Chemistry
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 862.3364
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QDJ is linked to regulation 21CFR862.3364, which does not seem to exist yet. It may be pending at the moment.