510(k) Report

FDA applicant

Nichols Institute Diagnostics

San Juan Capistrano, CA68 decisions1977–20055 recalls

FDA records 68 decisions for Nichols Institute Diagnostics (San Juan Capistrano, CA) from 1977 to 2005: 68 510(k) clearances. Most are in product codes CEW (Radioimmunoassay, Parathyroid Hormone) and CEP (Radioimmunoassay, Luteinizing Hormone). Its devices cite 12 predicates, 4 of them its own earlier devices. 5 recalls are 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 chemistry panel, where it files most

How often FDA has decided Nichols Institute Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nichols Institute Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nichols Institute Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CEWRadioimmunoassay, Parathyroid Hormone13decisions
  • CEPRadioimmunoassay, Luteinizing Hormone4decisions
  • CFLRadioimmunoassay, Human Growth Hormone4decisions
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone3decisions
  • CGJRadioimmunoassay, Follicle-Stimulating Hormone3decisions
  • JKRRadioimmunoassay, Calcitonin3decisions

Also: CGR (3), CKG (3), MSW (2), CIB (2), CEC (2), CJM (2).

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 4 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.

  • K954418Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 19952cite it
  • K013992Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) ImmunoassayNichols Institute Diagnostics · 20012cite it
  • K962598Nichols Advantage Chemiluminescence Intact Parathyroid Hormone KitNichols Institute Diagnostics · 19961cites it
  • K994140Nichols Chemiluminescence Thyroglobulin, Model 60-4240Nichols Institute Diagnostics · 20001cites it
  • K972070Nichols Advantage Chemiluminescence Tri-Level Specialty ControlsNichols Institute Diagnostics · 19971cites it
  • K964635Nichols Advantage Chemiluminescence Calcitonin KitNichols Institute Diagnostics · 19971cites it

What has FDA decided for it lately?

  • K050784Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2005
  • K042676Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) AssayNichols Institute Diagnostics · 20041 recall
  • K042689Nichols Advantage CortisolNichols Institute Diagnostics · 2004
  • K040813Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022Nichols Institute Diagnostics · 2004
  • K033727Nichols Advantage Bio-Intact PTH (1-84) ImmunoassayNichols Institute Diagnostics · 20041 recall
  • K033302Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040Nichols Institute Diagnostics · 2004
  • K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2003
  • K022356Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies ImmunoassayNichols Institute Diagnostics · 2002

All 68 as Nichols Institute Diagnostics →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K042676Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)Aug 31, 2005
  • K962601Nichols Advantage ACTH Test System, catalog number 62-7004.Apr 22, 2005
  • K033727Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040Apr 7, 2005
  • K861797Nichols IRMA Intact PTH Assay, catalog No. 40-2171Mar 25, 2005
  • K012367Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.Jun 30, 2004

Other applicant names beginning “Nichols”

FDA records each applicant name separately; these may or may not be the same firm.

Nichols Institute 15