510(k) Report

FDA applicant

Qingdao Hightop Biotech Co., Ltd.

Qingdao, CN3 decisions2019–20240 recalls

FDA records 3 decisions for Qingdao Hightop Biotech Co., Ltd. (Qingdao, CN) from 2019 to 2024: 3 510(k) clearances. Most are in product codes NFT (Test, Amphetamine, Over The Counter) and NGL (Test, Opiates, Over The Counter). Since 2016 its 510(k)s took a median of 40 days from receipt to decision, against 50 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Qingdao Hightop Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12022: 12024: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Qingdao Hightop Biotech Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • NFTTest, Amphetamine, Over The Counter1decision
  • NGLTest, Opiates, Over The Counter1decision
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 40 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 50 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid…Qingdao Hightop Biotech Co., Ltd. · 20241cites it
  • K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test…Qingdao Hightop Biotech Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid…Qingdao Hightop Biotech Co., Ltd. · 2024
  • K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxQingdao Hightop Biotech Co., Ltd. · 2022
  • K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test…Qingdao Hightop Biotech Co., Ltd. · 2019

All 3 as Qingdao Hightop Biotech Co., Ltd. →