Cleared Traditional

K930477 - ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR

K930477 is an FDA 510(k) clearance for ACS ANGIOTENSIN CONVERTING ENZYME (ACE)..., manufactured by Analytical Control Systems, Inc.. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K930477 · Analytical Control Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
129d
Days
Class 2
Risk

K930477 is an FDA 510(k) clearance for the ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 129 days - within the typical 510(k) review window.

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: 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.

View all Analytical Control Systems, Inc. devices

FDA 510(k) Submission Details - K930477

510(k) Number K930477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date June 07, 1993
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
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 - JIS Calibrator, Primary

All 112
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K930477.
DC-LINEATE CAT. NO. SE-091
K932555 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1993
DU PONT ACA NEV/EEV VERIFIER
K930501 · Dupont Medical Products · Aug 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646 · Behring Diagnostics, Inc. · Jun 1993
DC-UIBC-CAL
K925877 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1993
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992