510(k) Report

FDA applicant

Pointe Scientific, Inc.,

Lincoln Park, MI74 decisions1981–200781 recalls

FDA records 74 decisions for Pointe Scientific, Inc., (Lincoln Park, MI) from 1981 to 2007: 74 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and CFR (Hexokinase, Glucose). Its devices cite 1 predicate, 0 of them its own earlier devices. 81 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 Pointe Scientific, Inc.,’s devices, and how often a recall has named them.

FDA decisions per year

6in 2007

2007: 6
2007high 6 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007: 82008: 172009: 222011: 12012: 22014: 12015: 22018: 1
2007high 22 (2009) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Pointe Scientific, Inc., 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?

  • LCPAssay, Glycosylated Hemoglobin4decisions
  • CFRHexokinase, Glucose4decisions
  • JFJCatalytic Methods, Amylase4decisions
  • CIGDiazo Colorimetry, Bilirubin4decisions
  • CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides3decisions
  • CICCresolphthalein Complexone, Calcium3decisions

Also: KHS (3), CFJ (3), LBR (3), CGA (2), CKA (2), CIT (2).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K031539Hemoglobin A1C Reagent SetPointe Scientific, Inc., · 20032cite it
  • K921625Calcium-Arsenazo Iii Reagent SetPointe Scientific, Inc., · 19921cites it
  • K024006G6PDH, Glucose-6-Phoshate DehydrogenasePointe Scientific, Inc., · 20031cites it
  • K070251Carbon Dioxide Liquid Stable ReagentPointe Scientific, Inc., · 20071cites it
  • K002199Modification to Liquid Glucose (Hexokinase) Reagent SetPointe Scientific, Inc., · 20001cites it

What has FDA decided for it lately?

  • K070757Microprotein Reagent SetPointe Scientific, Inc., · 2007
  • K062118Pointe 360Pointe Scientific, Inc., · 2007
  • K070251Carbon Dioxide Liquid Stable ReagentPointe Scientific, Inc., · 2007
  • K070207Multi-Analyte Chemistry CalibratorPointe Scientific, Inc., · 2007
  • K070504Ammonia/Alcohol Control SetPointe Scientific, Inc., · 2007
  • K061377Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsPointe Scientific, Inc., · 2007
  • K051646Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighPointe Scientific, Inc., · 2005
  • K040391Total Bilirubin Reagent SetPointe Scientific, Inc., · 20043 recalls

All 74 as Pointe Scientific, Inc., →

What has been recalled?

81 recalls linked to its devices; the latest:

  • K992002Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product…Aug 10, 2018Class III
  • K024006Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1…May 19, 2015Class II
  • K992002Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE…Mar 13, 2015Class III
  • K830556Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic…Dec 12, 2014Class III
  • K040391Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry…Mar 13, 2012Class II
  • K941132Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE…Feb 15, 2012Class III

Other applicant names beginning “Pointe”

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

Pointe Conception Medical, Inc. 1