FDA Accelerates Home Test Approvals: POCT Is the Future

1：Policy Shift: Home Diagnostics Enter the Fast Lane

In the post-pandemic era, home testing is evolving from a temporary backup into a core tool for chronic disease management and public health. The FDA is accelerating the review of POCT devices via 510(k) and CLIA-waived programs, empowering use in homes, pharmacies, schools, and workplaces.

2：Key Highlights from the FDA Fast-Track Mechanism

The FDA created a 510(k) Subpart G fast track for low-risk home-use diagnostics

Multiple drug test and infectious disease kits have been CLIA-waived and approved for retail use

App-assisted + visual dual-readout approaches are being promoted

Average approval time has been reduced by over 30%, paving the way for mainstream OTC adoption

3：Conlight Product Suite: The New Home Health Toolkit

• Panel Drug Test + Urinalysis CUP
• Detects 12 major drugs including THC, COC, AMP, MOP, and K2
• ·Includes 12-parameter urinalysis for kidney, infection, and pH monitoring
• ·FDA-cleared under 510(k); suitable for home, educational, and employer screening

Food & Water Safety Combo Kits

Tests for Pesticide residues, antibiotics, glyphosate, and heavy metals

Uses dry chemistry paper for rapid visual readout

Designed for kitchens, baby food testing, and household water safety

Pet Diagnostics: Drug & Health Strip for Dogs/Cats

Detects THC, sedatives, and anti-anxiety medications in dog/cat urine

Includes colorimetric strips for glucose, protein, and hydration markers

Currently under FDA and veterinary network registration for pilot launch

4：POCT Trend: From Lab to Living Room

• According to Frost & Sullivan, the U.S. POCT market will reach $32 billion by 2025, with over one-third driven by home users. Key use cases include:

Parents tracking behavioral shifts in teens

Employers screening for safety-critical roles

Consumers checking for glyphosate or tap water contamination

Pet owners conducting at-home diagnostics and drug screening

5：Final Word: Rapid Testing is Not Just Tech, It’s Responsibility

Conlight will continue to launch safe, FDA-compliant, data-backed home testing kits for both human and pet health. We believe: one exaple, one test, one honest answer