Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace Ck Reagent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K123322 ↗

FDA Product Code

CDN

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• S40 Clinical Analyzer, S Test Alb

  Class II

  FDA 510(k) K072143 Active Cleared 14 Jul 2008

• S40 Clinical Analyzer, S Test Ip, S Test Ua

  Class I

  FDA 510(k) K072141 Active Cleared 24 Jun 2008

• Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides Reagent

  Class I

  FDA 510(k) K113262 Active Cleared 3 Jul 2012

• Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. Reagent

  Class II

  FDA 510(k) K113374 Active Cleared 13 Jul 2012

• Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent, Urine Standard

  Class II

  FDA 510(k) K103615 Active Cleared 8 Sep 2011

• Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent

  Class II

  FDA 510(k) K113437 Active Cleared 6 Aug 2012

See all devices from Alfa Wassermann Diagnostic Technologies, Inc. →

• What clinical chemistry systems are compatible with these ACE reagents, and how do I know if my lab equipment supports them?

  The ACE reagents are designed exclusively for use with the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. These systems are specifically engineered to process the urease-based photometric assays for BUN, creatinine, uric acid, and CK. Before purchasing, verify your lab’s existing analyzer model against the manufacturer’s compatibility list to ensure seamless integration.

• Are these reagents single-use or reusable, and what does that mean for my lab’s workflow?

  These reagents are intended for single-use only, meaning each vial is meant to be used once before disposal. This design minimizes contamination risk and ensures consistent, accurate results per the manufacturer’s instructions. Your lab should account for this in inventory management and workflow planning to avoid waste or cross-contamination.

• Do these reagents require special handling or sterility measures beyond standard lab practices?

  No special sterility measures are required beyond standard laboratory handling practices. The reagents are supplied as liquid formulations for clinical chemistry use and are not classified as sterile medical devices. Adhere to general aseptic techniques when preparing samples to maintain accuracy and safety.

• What storage conditions should I follow to maintain the reagents’ performance and validity?

  Storage conditions are outlined in the manufacturer’s instructions, which you must follow to preserve reagent integrity. While the data does not specify exact storage details, typical photometric reagents like these are generally stored at 2–8°C (refrigerated) and protected from light. Always check the accompanying documentation for precise guidelines to avoid degradation or inaccurate test results.

• How do I confirm these reagents are compliant with FDA requirements, and what does the ‘FDA 510(k)’ clearance mean for my lab?

  These reagents hold an FDA 510(k) clearance under the Clinical Chemistry advisory committee, classified as Class II, with a decision of *Substantially Equivalent* (SESE). This means the FDA has determined they meet performance standards for urease-based photometric assays and are comparable to legally marketed predecessors. Your lab can verify compliance by checking the K-number (K123322) and reviewing the manufacturer’s documentation for full regulatory details.