Evaluation of Automatic Class III Designation

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket notification [510(k)] submissions.

Latest De Novo Classifications

ManufacturerDevice NameDate
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit2019-05-23
ZIKV Detect 2.0 IgM Capture ELISA2019-05-23
Nerivio Migra2019-05-20
Comaneci, Comaneci Petit, Comaneci 172019-04-24
PREVENA 125 And PREVENA PLUS 125 Therapy Units2019-04-19
Monarch ETNS System2019-04-19
Plenity2019-04-12
LOADPRO™ Intraoperative Rod Strain Sensor2019-03-28
Leica FL4002019-03-28
ClearMate2019-03-14
Quantra Hemostasis Analyzer, QPlus Cartridge2019-03-12
Early Bird Bleed Monitoring System2019-03-01
T:slim X2 Insulin Pump With Interoperable Technology2019-02-14
Aptima Mycoplasma Genitalium Assay2019-01-23
EyeBOX2018-12-28
MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe K2018-12-21
Miris Human Milk Analyzer2018-12-21
SEM Scanner (Model 200)2018-12-20
Enlight 18102018-12-20
Retrograde Intubation Set2018-12-12
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit2018-11-30
QMS Plazomicin Immunoassay2018-11-19
Innovo2018-11-06
Parathyroid Detection (Model PTeye) System2018-11-02
Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System2018-11-02
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports2018-10-31
PicoAMH ELISA2018-10-24
Bose Hearing Aid2018-10-05
Adaptive Biotechnologies ClonoSEQ Assay2018-09-28
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET2018-09-21
Irregular Rhythm Notification Feature2018-09-11
ECG App2018-09-11
MATRx Plus2018-08-23
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System2018-08-17
Natural Cycles2018-08-10
MolecuLight I:X2018-07-31
Bonebridge2018-07-20
EverlinQ EndoAVF System2018-06-22
Ellipsys Vascular Access System2018-06-22

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