Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: JJF FDA class 1

Analyzer, Chemistry, Micro, For Clinical Use

Clinical Chemistry

View full classification →

This device is a micro-scale clinical chemistry analyzer designed to perform quantitative biochemical testing on small sample volumes, suitable for applications such as neonatal testing or point-of-care settings where specimen availability is limited. It is classified as FDA Class 1, indicating low risk and requiring only general controls with no premarket notification. The product code is JJF, regulated under 21 CFR 862.2170, and belongs to the Clinical Chemistry medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K052794

ETI-MAX 3000

Mar 31, 2006

Substantially Equivalent

DIASORIN, INC.

K040332

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

Jun 16, 2004

Substantially Equivalent

ARKRAY, INC.

K033734

LIGHTCYCLER INSTRUMENT VERSION 1.2

Dec 17, 2003

Substantially Equivalent

ROCHE DIAGNOSTICS CORP.

K013654

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

Jun 05, 2002

Substantially Equivalent

PRECISION SYSTEMS, INC.

K012966

ROCHE COBAS TAQMAN ANALYZER

Feb 01, 2002

Substantially Equivalent

ROCHE MOLECULAR SYSTEMS, INC.

K993634

CARESIDE ANALYZER

Dec 02, 1999

Substantially Equivalent

CARESIDE, INC.

K973628

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

Mar 13, 1998

Substantially Equivalent

VITAL SCIENTIFIC N.V.

K980056

CARESIDE ANALYZER

Mar 06, 1998

Substantially Equivalent

EXIGENT DIAGNOSTICS, INC.

K973177

MAGO AUTOMATED EIA PROCESSOR

Oct 09, 1997

Substantially Equivalent

DIAMEDIX CORP.

K971491

SYNERMED IR 200 CHEMISTRY ANALYZER

Jun 26, 1997

Substantially Equivalent

SYNERMED, INC.

K964506

ROCHE COBAS AMPLICOR ANALYZER

May 21, 1997

Substantially Equivalent

ROCHE MOLECULAR SYSTEMS, INC.

K965103

WINMAX SOFTWARE SYSTEMS

May 09, 1997

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K964409

HCL - 200 BIOCHEMISTRY ANALYZER

Jan 22, 1997

Substantially Equivalent

HCL LABORATORY SYSTEMS, INC.

K961209

BRIO AUTOMATIC SAMPLINC UNIT

Dec 24, 1996

Substantially Equivalent

SEAC S.R.L.

K943978

WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS

May 02, 1995

Substantially Equivalent

WATERS CHROMATOGRAPHY DIVISION

K942676

SYNCHRON CX3 DELTA

Nov 02, 1994

Substantially Equivalent

BECKMAN-DIAGNOSTIC SYSTEMS GROUP

K925093

SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA

Nov 16, 1993

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K912055

SYVA EDMS

Jun 10, 1991

Substantially Equivalent

SYVA CO.

K903357

SYVA(R) ETS(R) PLUS SYSTEM

Sep 27, 1990

Substantially Equivalent

SYVA CO.

K893768

MODIFIED PK300 AUTOMATIC EIA ANALYZER

Aug 15, 1989

Substantially Equivalent

OLYMPUS CORP.

K883298

RECONDITIONED ASTRA (TM) 8

Mar 16, 1989

Substantially Equivalent

ASSOCIATED ELECTRO-MEDICAL SERVICES, INC.

K883350

RECONDITIONED ASTRA(TM) 4

Mar 16, 1989

Substantially Equivalent

ASSOCIATED ELECTRO-MEDICAL SERVICES, INC.

K883020

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

Sep 02, 1988

Substantially Equivalent

ALPKEM CORP.

K872120

SERALYZER III BLOOD CHEMISTRY ANALYZER

Oct 28, 1987

Substantially Equivalent

MILES LABORATORIES, INC.

K871486

(FPIA) ASSAY BUFFER

May 08, 1987

Substantially Equivalent

WINDSOR LABORATORIES, INC.

K863245

SYVA ETS SYSTEM

Mar 13, 1987

Substantially Equivalent

SYVA CO.

K870777

PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER

Mar 13, 1987

Substantially Equivalent

KONE INSTRUMENTS, INC.

K864834

OLYMPUS PK300

Feb 20, 1987

Substantially Equivalent

OLYMPUS CORP.

K864236

SYNCHRON CX3

Dec 31, 1986

Substantially Equivalent

BECKMAN INSTRUMENTS, INC.

K852385

HYBRITECH IMMUNOCHEMISTRY ANALYZER

Jul 12, 1985

Substantially Equivalent

HYBRITECH, INC.

K851933

CLINICAL CHEMISTRY ANALYTICAL SYSTEM

Jun 10, 1985

Substantially Equivalent

ALLIED INSTRUMENTATION LABORATORY

K851542

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

May 10, 1985

Substantially Equivalent

ALPKEM CORP.

K851172

COBAS MIRA

May 02, 1985

Substantially Equivalent

ROCHE DIAGNOSTIC SYSTEMS, INC.

K850999

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN

Apr 08, 1985

Substantially Equivalent

TECHNICON INSTRUMENTS CORP.

K844586

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS

Dec 11, 1984

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K840200

PROGRESS SELECTIVE DHEMISTRY ANALYZ

Apr 04, 1984

Substantially Equivalent

KONE INSTRUMENTS, INC.

K833998

QCA CHEMISTRY ANALYZER

Jan 30, 1984

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K833804

SHABAN 9865 IL#78637 JUNCTION BLOC

Jan 13, 1984

Substantially Equivalent

SHABAN MFG. CO.

K833154

NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM

Dec 08, 1983

Substantially Equivalent

NOVA BIOMEDICAL CORP.

K833153

NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU

Nov 25, 1983

Substantially Equivalent

NOVA BIOMEDICAL CORP.

K831227

COMPUR EASY TOUCH CHEMISTRY ANALYZER-

Jun 02, 1983

Substantially Equivalent

WORTHINGTON DIAGNOSTIC SYSTEMS

K830095

RAPID CHEM ANALYZER II

Jan 28, 1983

Substantially Equivalent

MACOMB CHEMICAL CO.

K821583

AMES/GILFORD OPTIMATE CLIN. CHEM & THER

Jun 24, 1982

Substantially Equivalent

GILFORD INSTRUMENT LABORATORIES, INC.

K820541

MICROLYTE

May 24, 1982

Substantially Equivalent

KONE INSTRUMENTS, INC.

K820748

POLI-MAK MODEL F-4 (FINAL

Apr 06, 1982

Substantially Equivalent

PM AMERICA, INC.

K820415

4150 ALPHA AMINO ACID ANALYZER

Mar 11, 1982

Substantially Equivalent

LKB INSTRUMENTS, INC.

K803004

AMINO ACID ANALYSER SYSTEM

Dec 22, 1980

Substantially Equivalent

LKB INSTRUMENTS, INC.

K802398

ELECTROLY TE CHEMISTRY ANALYZER

Oct 31, 1980

Substantially Equivalent

INSTRUMENTATION LABORATORY CO.

K802264

WASH SOLUTION KIT, #88102

Oct 31, 1980

Substantially Equivalent

HI CHEM, INC.

K802392

ASTRA PRINTER PAPER #88112-CHLORIDE SILV

Oct 23, 1980

Substantially Equivalent

HI CHEM, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

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