Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models K1270, KC270

510(k) K090330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK090330	Date22 May 2009Cleared	StatusActive

5 recalls · FDA

- Terminated Z-2285-2020 FDA Class II initiated 4 May 2020
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- Terminated Z-1233-2020 FDA Class II initiated 18 Dec 2019
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- Terminated Z-1664-2016 FDA Class II initiated 17 Mar 2016
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
- Terminated Z-2154-2011 FDA Unclassified (pre-2012) initiated 10 Jun 2010
Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
- Terminated Z-2419-2010 FDA Unclassified (pre-2012) initiated 12 Feb 2010
The ECREA test results may be falsely elevated or depressed.

1 jurisdiction

United States — FDA 510(k) Active

510(k)