Product code DFC
- Device name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5600
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | 2025-01-24 |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | 2022-12-22 |
| K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | 2018-03-22 |
| K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 |
| K122722 | COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 | Roche Diagnostics | 2012-11-29 |
| K082488 | DIAZYME LP(A) ASSAY | General Atomics | 2009-01-13 |
| K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH | Thermo Electron OY | 2007-09-27 |
| K050487 | QUANTIA LA(A) | Biokit, S.A. | 2005-04-26 |
| K023853 | K-ASSAY LP(A) CONTROLS | Kamiya Biomedical Co. | 2002-12-13 |
| K021660 | K-ASSAY LP(A) ASSAY | Kamiya Biomedical Co. | 2002-07-25 |
| K013359 | LP(A)-LATEX SEIKEN ASSAY KIT | Denka Seiken'S | 2002-03-08 |
| K013128 | N LATEX LP(A) | Dade Behring, Inc. | 2002-01-18 |
| K013206 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-16 |
| K013207 | TINA-QUANT APOLIPOPROTEIN B VER.2 | Roche Diagnostics Corp. | 2001-11-13 |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | 2000-07-24 |
| K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | 2000-07-24 |
| K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | 2000-07-24 |
| K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | 2000-07-24 |
| K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | 2000-07-23 |
| K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | 2000-07-23 |
| K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION | Wako Chemicals USA, Inc. | 2000-07-23 |
| K000121 | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB | Beckman Coulter, Inc. | 2000-05-17 |
| K001118 | MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 2000-04-25 |
| K994110 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | Diasorin/American Standard Companies | 1999-12-21 |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | Trinity Biotech USA | 1999-11-26 |
| K993669 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | 1999-11-17 |
| K990595 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B | Roche Diagnostics Corp. | 1999-04-14 |
| K982708 | SPQ TEST SYSTEM | DiaSorin, Inc. | 1999-04-02 |
| K981446 | WAKO AUTOKIT LP(A) | Wako Chemicals USA, Inc. | 1999-03-09 |
| K983281 | APOB | Abbott Laboratories | 1999-01-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336237397 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics GmbH | 2025-05-27 |
| 07613336237403 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics GmbH | 2025-05-27 |
| 07613336237380 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics GmbH | 2025-05-27 |
| 08058056680211 | Lp(a) Ultra | SENTINEL CH. SPA | 2024-03-15 |
| 05055273204445 | LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) | RANDOX LABORATORIES LIMITED | 2022-10-05 |
| 00380740170165 | ARCHITECT | ABBOTT IRELAND | 2022-03-16 |
| 00380740170158 | Alinity | ABBOTT IRELAND | 2021-05-19 |
| 00811727016225 | Pointe Lp(a) Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00811727015921 | Pointe Lp(a) Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00380740175146 | ARCHITECT | Abbott GmbH | 2020-12-15 |
| 07613336140833 | Tina-quant Lipoprotein (a) Gen.2 | Roche Diagnostics GmbH | 2020-03-16 |
| 07613336133538 | Tina-quant Apolipoprotein B ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156435 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740154509 | Alinity | Abbott GmbH | 2019-09-09 |
| 00380740153847 | Alinity | ABBOTT LABORATORIES | 2019-05-10 |
| 00817302022315 | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2018-09-07 |
| 00817302022308 | CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2018-09-07 |
| 05055273204384 | Lp (a) | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05051700016841 | Lipoprotein (a) Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 04015630930586 | Tinaquant Lipoprotein a Gen.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630930234 | Tinaquant Apolipoprotein B ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630929962 | Tinaquant Lipoprotein a Gen.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928668 | Tinaquant Apolipoprotein B ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630917754 | Tinaquant Apolipoprotein B ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630917730 | Tinaquant Apolipoprotein B ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590221171 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 05055845400022 | Axis-Shield Homocysteine Controls | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-07-01 |
| 05055845400015 | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-06-13 |
| M2045020011 | TorqMax™ | Spectranetics Corporation | 2014-08-19 |
| M2045020010 | TorqMax™ | Spectranetics Corporation | 2014-08-19 |