Cleared Traditional

K871150 - ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRA...

K871150 is an FDA 510(k) clearance for ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRA..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K871150 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
64d
Days
Class 2
Risk

K871150 is an FDA 510(k) clearance for the ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K871150

510(k) Number K871150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1987
Decision Date May 26, 1987
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 173
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K871150.
BILE ACIDS CALIBRATOR
K872451 · Sigma Diagnostics, Inc. · Aug 1987
TOTAL BILIRUBIN STANDARD CALIBRATOR
K872263 · Wako Chemicals USA, Inc. · Jul 1987
CREATININE STANDARD SOLUTION CALIBRATOR
K871756 · Wako Chemicals USA, Inc. · May 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
K871758 · Wako Chemicals USA, Inc. · May 1987
MAGNESIUM STANDARD SOLUTION CALIBRATOR
K871762 · Wako Chemicals USA, Inc. · May 1987
NEFA STANDARD SOLUTION CALIBRATOR
K871763 · Wako Chemicals USA, Inc. · May 1987