Nichols Institute Diagnostics
San Juan Capistrano, CA, US
Nichols Institute Diagnostics appears in FDA device records in San Juan Capistrano, CA. FDA records list 68 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 10 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Nichols Institute Diagnostics between 1977 and 2005. The busiest year on record is 1997, with 7. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 2 |
| 1979 | 1 |
| 1984 | 6 |
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 7 |
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | CJM | Substantially Equivalent | |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | DHA | Substantially Equivalent | |
| K042689 | NICHOLS ADVANTAGE CORTISOL | CGR | Substantially Equivalent | |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | CEW | Substantially Equivalent | |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | CEW | Substantially Equivalent | |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | CEW | Substantially Equivalent | |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | CJM | Substantially Equivalent | |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | LYR | Substantially Equivalent | |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | CEW | Substantially Equivalent | |
| K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY | CEW | Substantially Equivalent | |
| K012367 | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D | JIT | Substantially Equivalent | |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | CIB | Substantially Equivalent | |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | MSW | Substantially Equivalent | |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | MSW | Substantially Equivalent | |
| K992188 | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 | JNM | Substantially Equivalent | |
| K980737 | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | GGT | Substantially Equivalent | |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | CGR | Substantially Equivalent | |
| K984186 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY | DBF | Substantially Equivalent | |
| K983992 | NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY | JZO | Substantially Equivalent | |
| K982866 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 | JZO | Substantially Equivalent | |
| K980716 | ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY | LTJ | Substantially Equivalent | |
| K972070 | NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS | JJY | Substantially Equivalent | |
| K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT | JKR | Substantially Equivalent | |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | CGR | Substantially Equivalent | |
| K962687 | GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM | JQW | Substantially Equivalent | |
| K962408 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT | CEC | Substantially Equivalent | |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | CDP | Substantially Equivalent | |
| K961142 | STRATEC LIA II ANALYZER | JJE | Substantially Equivalent | |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | CKG | Substantially Equivalent | |
| K962598 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT | CEW | Substantially Equivalent | |
| K962033 | CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT | CEW | Substantially Equivalent | |
| K961650 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT | JLW | Substantially Equivalent | |
| K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT | CFL | Substantially Equivalent | |
| K945961 | CALCITONIN IMMUNOASSAY KIT | JKR | Substantially Equivalent | |
| K954418 | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) | CEW | Substantially Equivalent | |
| K950029 | 5STRATEC SL 300 LIA-MAT | JJQ | Substantially Equivalent | |
| K950921 | CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY | JLW | Substantially Equivalent | |
| K935319 | CHEMILUMINESCENCE LH | CEP | Substantially Equivalent | |
| K926220 | T3 UPTAKE CHEMILUMINESCENCE ASSAY | KHQ | Substantially Equivalent | |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | CIB | Substantially Equivalent | |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | MSJ | Substantially Equivalent | |
| K923015 | TOTAL T3 CHEMILUMINESCENCE ASSAY | CDP | Substantially Equivalent | |
| K896808 | IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I | CFL | Substantially Equivalent | |
| K896222 | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT | CEC | Substantially Equivalent | |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | CKG | Substantially Equivalent | |
| K881123 | ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. | CGJ | Substantially Equivalent | |
| K881124 | ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY | CEP | Substantially Equivalent | |
| K874572 | ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM | DBF | Substantially Equivalent | |
| K872390 | ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM | JHI | Substantially Equivalent | |
| K863679 | ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM | CEP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MSJApolipoproteins
- GGTAssay, Erythropoietin
- DIDBacillus Subtilis Microbiology Assay, Tobramycin
- JITCalibrator, Secondary
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DBFFerritin, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- DGOIge, Peroxidase, Antigen, Antiserum, Control
- JNMImmunochemical, Transferrin
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- KHQRadioassay, Triiodothyronine Uptake
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIBRadioimmunoassay, Angiotensin I And Renin
- JKRRadioimmunoassay, Calcitonin
- CGRRadioimmunoassay, Cortisol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- JQWStation, Pipetting And Diluting, For Clinical Use
- DHASystem, Test, Human Chorionic Gonadotropin
- MSWSystem, Test, Thyroglobulin
- JZOSystem, Test, Thyroid Autoantibody
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0136-06 | Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512 | Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2. | Terminated | ||
| Z-0007-06 | Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) | Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. | Terminated | ||
| Z-0006-06 | Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052) | Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. | Terminated | ||
| Z-0873-05 | Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756) | Under recovery of diluted samples by as much as 20%. | Terminated | ||
| Z-0874-05 | Nichols Advantage TSH - Third Generation | Does not meet performance claims in the labeling. | Terminated | ||
| Z-1044-05 | Nichols Advantage ACTH Test System, catalog number 62-7004. | Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay. | Terminated | ||
| Z-0056-06 | Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045. | Controls were out of specification range. | Terminated | ||
| Z-0810-05 | Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 | Values do not agree with Directional Instructions. | Terminated | ||
| Z-0809-05 | Nichols IRMA Intact PTH Assay, catalog No. 40-2171 | Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling. | Terminated | ||
| Z-1118-04 | Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. | Lower than expected results are obtained. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain