Cleared Traditional

K852760 - LBK 1244 DELFIA HCG KIT

K852760 is an FDA 510(k) clearance for LBK 1244 DELFIA HCG KIT, manufactured by Lkb Instruments, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K852760 · Lkb Instruments, Inc. · Chemistry device
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Dec 1985
Decision
160d
Days
Class 2
Risk

K852760 is an FDA 510(k) clearance for the LBK 1244 DELFIA HCG KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 160 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K852760

510(k) Number K852760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date December 05, 1985
Days to Decision 160 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
71d slower than avg
Panel avg: 89d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K852760.
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K854059 · Bioclinical Systems, Inc. · Jan 1986
CANWEST-PREGBLUE
K854989 · Canwest Medictex, Inc. · Jan 1986
RAMP URINE HCG ASSAY
K854611 · Monoclonal Antibodies, Inc. · Dec 1985
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
K854104 · Immunchem Corp. · Dec 1985
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
K853925 · Nms Pharmaceuticals, Inc. · Dec 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024 · Corning Medical & Scientific · Nov 1985
K852760 · LBK 1244 DELFIA HCG KIT
Download PDF Lkb Instruments, Inc.