510(k) Report

FDA applicant

Advin Biotech, Inc.

San Diego, CA4 decisions2013–20250 recalls

FDA records 4 decisions for Advin Biotech, Inc. (San Diego, CA) from 2013 to 2025: 4 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and NFT (Test, Amphetamine, Over The Counter). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 37 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Advin Biotech”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Advin Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12019: 12020: 12025: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Advin Biotech, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advin Biotech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DJGEnzyme Immunoassay, Opiates2decisions
  • NFTTest, Amphetamine, Over The Counter1decision
  • DKZEnzyme Immunoassay, Amphetamine1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 37 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 201312cite it
  • K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 20193cite it

What has FDA decided for it lately?

  • K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc. · 2025
  • K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 2020
  • K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. · 2019
  • K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013

All 3 as Advin Biotech, Inc. →The one decision as Advin Biotech →