Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pointe Scientific, Inc., — Predicate Candidate Screening
74 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
159 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Pointe Scientific, Inc., | 2007-12-04 | 259 | 0 |
| K062118 | POINTE 360 | Pointe Scientific, Inc., | 2007-07-13 | 353 | 0 |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | 2007-04-30 | 94 | 0 |
| K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | Pointe Scientific, Inc., | 2007-04-13 | 81 | 0 |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | Pointe Scientific, Inc., | 2007-04-11 | 49 | 0 |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRAT | Pointe Scientific, Inc., | 2007-03-28 | 315 | 0 |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LO | Pointe Scientific, Inc., | 2005-10-07 | 108 | 0 |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Pointe Scientific, Inc., | 2004-06-02 | 106 | 3 |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Pointe Scientific, Inc., | 2003-08-06 | 82 | 0 |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Pointe Scientific, Inc., | 2003-04-28 | 159 | 0 |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | 2003-03-31 | 117 | 1 |
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | 2002-12-23 | 75 | 0 |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | 2000-11-20 | 123 | 14 |
| K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | Pointe Scientific, Inc., | 2000-10-13 | 49 | 0 |
| K993590 | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | Pointe Scientific, Inc., | 1999-12-21 | 60 | 0 |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | Pointe Scientific, Inc., | 1999-08-05 | 51 | 12 |
| K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALI | Pointe Scientific, Inc., | 1998-07-22 | 47 | 0 |
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | Pointe Scientific, Inc., | 1997-10-22 | 30 | 18 |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | Pointe Scientific, Inc., | 1997-10-10 | 49 | 0 |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | 1997-10-08 | 16 | 1 |
| K972725 | ALCOHOL REAGENT SET | Pointe Scientific, Inc., | 1997-09-25 | 66 | 0 |
| K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | 1997-07-22 | 71 | 1 |
| K972671 | BUN (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-07-20 | 4 | 0 |
| K970933 | AUTO HDL CHOLESTEROL CALIBRATOR | Pointe Scientific, Inc., | 1997-05-23 | 71 | 0 |
| K970781 | LIQUID GLUCOSE (OXIDASE) REAGENT SET | Pointe Scientific, Inc., | 1997-04-21 | 48 | 0 |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-03-11 | 26 | 2 |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | 1996-11-18 | 208 | 0 |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Pointe Scientific, Inc., | 1996-06-03 | 49 | 0 |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | 1994-08-01 | 165 | 0 |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | Pointe Scientific, Inc., | 1994-05-03 | 47 | 8 |
| K941132 | LIQUID AST (SGOT)REAGENT SET | Pointe Scientific, Inc., | 1994-05-02 | 54 | 3 |
| K935463 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Pointe Scientific, Inc., | 1994-01-11 | 60 | 0 |
| K930475 | LIQUID AMYLASE REAGENT SET | Pointe Scientific, Inc., | 1993-07-19 | 172 | 0 |
| K930660 | CREATINE KINASE (CK) REAGENT SET | Pointe Scientific, Inc., | 1993-03-29 | 48 | 0 |
| K920449 | POINTE 750 GLYCOMETER | Pointe Scientific, Inc., | 1992-07-28 | 177 | 0 |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | 1992-05-13 | 37 | 0 |
| K914873 | DIAZO COLORIMETRY, BILIRUBIN | Pointe Scientific, Inc., | 1991-12-04 | 36 | 0 |
| K910158 | AMYLASE | Pointe Scientific, Inc., | 1991-04-30 | 105 | 0 |
| K896812 | CARBON DIOXIDE REAGENT | Pointe Scientific, Inc., | 1990-02-23 | 81 | 0 |
| K896590 | CARBON DIOXIDE REAGENT | Pointe Scientific, Inc., | 1990-02-01 | 72 | 0 |
| K891117 | HDL CHOLESTEROL REAGENT | Pointe Scientific, Inc., | 1989-04-10 | 39 | 0 |
| K874131 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Pointe Scientific, Inc., | 1987-12-04 | 52 | 0 |
| K864882 | FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY | Pointe Scientific, Inc., | 1987-01-21 | 40 | 8 |
| K864464 | PSI AMYLASE REAGENT | Pointe Scientific, Inc., | 1987-01-21 | 70 | 0 |
| K863832 | NAPHTHYL PHOSPHATE, ACID PHOSPHATASE | Pointe Scientific, Inc., | 1986-12-16 | 77 | 0 |
| K862033 | TRIGLYCERIDES | Pointe Scientific, Inc., | 1986-07-22 | 55 | 0 |
| K860572 | GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET | Pointe Scientific, Inc., | 1986-05-16 | 91 | 0 |
| K860257 | DIRECT BILIRUBIN | Pointe Scientific, Inc., | 1986-02-21 | 28 | 0 |
| K853592 | MAGNESIUM | Pointe Scientific, Inc., | 1985-09-16 | 20 | 0 |
| K852169 | CHLORIDE REAGENT | Pointe Scientific, Inc., | 1985-08-21 | 93 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda