CEF · Electrophoretic, Protein Fractionation
Clinical Chemistry · 21 CFR 862.1630 · Class 1
Overview
| Product Code | CEF |
|---|---|
| Device Name | Electrophoretic, Protein Fractionation |
| Regulation | 21 CFR 862.1630 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (29)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT | Sebia | Jul 26, 2013 | SESE |
| K972274 | SPIFE | Helena Laboratories | Oct 27, 1997 | SESE |
| K973316 | REP SPE VIS-60/40 KIT | Helena Laboratories | Oct 1, 1997 | SESE |
| K963018 | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS | Bio-Rad | Jun 4, 1997 | SESE |
| K964453 | REP 3 FLUR SPE-60 KIT | Helena Laboratories | Dec 23, 1996 | SESE |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | Morax | Jul 17, 1996 | SESE |
| K951536 | HYDRAGEL PROTEIN(E) KIT | Sebia | Jun 30, 1995 | SESE |
| K930317 | REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 | Helena Laboratories | Aug 3, 1993 | SESE |
| K922053 | REP SPE PLUS (PONCEAU S) SYSTEM | Helena Laboratories | Aug 18, 1992 | SESE |
| K922024 | REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 | Helena Laboratories | Jul 23, 1992 | SESE |
| K913315 | BIO-RAD TOTAL PROTEIN TEST KIT | Bio-Rad | Jan 2, 1992 | SESE |
| K913807 | REP(R) SPE TEMPLATE 30, 16, & 8 | Helena Laboratories | Nov 27, 1991 | SESE |
| K913058 | REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 | Helena Laboratories | Oct 30, 1991 | SESE |
| K912386 | REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 | Helena Laboratories | Jul 17, 1991 | SESE |
| K911468 | REP SPE PLUS (ACID BLUE) SYSTEM | Helena Laboratories | Apr 16, 1991 | SESE |
| K900251 | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 | Helena Laboratories | Feb 26, 1990 | SESE |
| K894585 | REP TM SPE (PONCEAU S) PROCEDURES | Helena Laboratories | Sep 13, 1989 | SESE |
| K893211 | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 | Helena Laboratories | Jun 19, 1989 | SESE |
| K870958 | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 | Helena Laboratories | Apr 29, 1987 | SESE |
| K843397 | CORNING HIGH RESOLUTION PROTEIN ELECTRO | Corning Medical & Scientific | Sep 14, 1984 | SESE |
| K833855 | TITAN GEL SILVER STAIN SYSTEM | Helena Laboratories | Feb 27, 1984 | SESE |
| K811725 | TBG DIAGNOSTIC KIT | Immuno Assay Corp. | Jul 10, 1981 | SESE |
| K802592 | PARAGON SERUM PROTEIN ELECTROPHORESIS | Beckman Instruments, Inc. | Nov 12, 1980 | SESE |
| K781123 | PONCEAU S | Electrophoresis Corp. of America | Aug 10, 1978 | SESE |
| K781120 | TRICHLORACETIC ACID 7.5% | Electrophoresis Corp. of America | Aug 10, 1978 | SESE |
| K781118 | ECA BUFFER PH 8.8 | Electrophoresis Corp. of America | Aug 10, 1978 | SESE |
| K781117 | ECA PREP | Electrophoresis Corp. of America | Aug 10, 1978 | SESE |
| K781116 | ECA BUFFER, PH 816 | Electrophoresis Corp. of America | Aug 10, 1978 | SESE |
| K771720 | AMIDO BLACK CONCENTRATE | Sigma Chemical Co. | Nov 3, 1977 | SESE |
Top Applicants
- Helena Laboratories — 15 clearances
- Electrophoresis Corp. of America — 5 clearances
- Sebia — 2 clearances
- Bio-Rad — 2 clearances
- Sigma Chemical Co. — 1 clearance
