Cleared Traditional

binx io CT/NG Assay and binx io CT/NG System (K200533) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence.

K200533 · Binx Health, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
56d
Days
Class 2
Risk

K200533 is an FDA 510(k) clearance for the binx io CT/NG Assay and binx io CT/NG System. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Binx Health, Inc. (Boston, US). The FDA issued a Cleared decision on April 27, 2020 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Binx Health, Inc. devices

Submission Details

510(k) Number K200533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date April 27, 2020
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3393
Definition A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03071510 Completed Observational Industry-sponsored

Evaluation of the Atlas Genetics io® CTNG System

IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings

7128
Patients (actual)
10
Sites
Condition studied Chlamydia Trachomatis; Gonorrhea
Eligibility All sexes · 14 Years+ · Healthy volunteers accepted
Principal investigator Barbara Van der Pol, PhD
Sponsor Binx Health Limited (industry)
Started 2017-05-18 → Primary completion 2019-08-30
Primary outcome
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

All 22
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to K200533.
cobas liat CT/NG nucleic acid test
K253756 · Roche Molecular Systems, Inc. · May 2026
cobas liat CT/NG/MG nucleic acid test
K253759 · Roche Molecular Systems, Inc. · May 2026
Visby Medical Men's Sexual Health Test
K251501 · Visby Medical, Inc. · Oct 2025
BD CTGCTV2
K243343 · Bd Integrated Diagnostic Solutions/Becton, · Apr 2025
cobas® liat CT/NG nucleic acid test
K240217 · Roche Molecular Systems, Inc. · Jan 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · Roche Molecular Systems, Inc. · Jan 2025