Cleared Traditional

K862027 - LDP REAGENT CARTRIDGE (NO. 88216)

K862027 is the FDA 510(k) clearance for LDP REAGENT CARTRIDGE (NO. 88216) by Hi Chem, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K862027 · Hi Chem, Inc. · Chemistry device
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Jun 1986
Decision
16d
Days
Class 2
Risk

K862027 is an FDA 510(k) clearance for the LDP REAGENT CARTRIDGE (NO. 88216). Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hi Chem, Inc. devices

Submission Details

510(k) Number K862027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date June 13, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 83
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K862027.
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · Em Diagnostic Systems, Inc. · Sep 1986
KING DIAGNOSTICS LDH TEST
K862306 · King Diagnostics, Inc. · Aug 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · Sterling Diagnostics, Inc. · Jul 1986
LACTATE DEHYDROGENASE (LD) PROCEDURE
K861662 · Data Medical Associates, Inc. · May 1986
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE
K861419 · Hi Chem, Inc. · Apr 1986
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713 · Catachem, Inc. · Apr 1986