510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

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

K090330510(k) TraditionalCleared May 22, 2009101-day reviewClass II21 CFR 862.1225Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics, Inc. · JFY Enzymatic Method, Creatinine

Cleared on May 22, 2009 as substantially equivalent to K003261 (Roche Diagnostics Corp., 2000) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1986. It has been recalled 5 times.

Decided
May 22, 2009
Review
101 days
Class
Class II
Product code
JFY
Recalls
5
Predicates
2

Its longest line of descent runs back 1 generation to K860021 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled0
  1. Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
  2. This deviceK090330 Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and…Siemens Healthcare Diagnostics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K860021Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.19861
0 (this device)K090330Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic…Siemens Healthcare Diagnostics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K090330, 1986–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JFY device

  1. #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003261Creatinine Plus
Summary page 2
…te device used to demonstrate substantial equivalence to the Dimension Vista® ECREA Flex® reagent cartridge is the Roche Creatinine Plus Reagent previously cleared under K003261. The predicate device used to demonstrate substantial equivalence to the Dimension® Chem I Cal (DC18B) previously cleared under…
Roche Diagnostics Corp.20001
*K860021Dimension (TM) Clinical Chemistry System
Summary page 2
…Reagent previously cleared under K003261. The predicate device used to demonstrate substantial equivalence to the Dimension® Chem I Cal (DC18B) previously cleared under K860021. G. Device Description: The Dimension Vista® ECREA Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method tha…
E.I. Dupont DE Nemours & Co., Inc.19861

Also cleared against K003261: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 4, 2020Class IIZ-2285-2020Device DesignThe presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Dec 18, 2019Class IIZ-1233-2020Under Investigation by firmThere 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.
Mar 17, 2016Class IIZ-1664-2016Device DesignSiemens 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…
Jun 10, 2010Not classifiedZ-2154-2011Device DesignResults may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
Feb 12, 2010Not classifiedZ-2419-2010Nonconforming Material/ComponentThe ECREA test results may be falsely elevated or depressed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K003261.

How does its category compare?

All JFY devices

JFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JFY

2in 2021

2007: 82008: 42009: 32011: 22014: 22016: 12017: 12018: 22019: 22021: 22026 (partial year): 1
2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007: 193 days median2008: 170 days median2009: 59 days median
2007high 193 (2007) · low 59 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JFY

1in 2013

2008: 22009: 32010: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JFY

61in 2025

2007: 12008: 42009: 222010: 222011: 422012: 242013: 392014: 42015: 72016: 162017: 162018: 342019: 562020: 342021: 572022: 92023: 362024: 342025: 61
2007high 61 (2025) · low 1 (2007)2025

MAUDE reports naming product code JFY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007819301
2008417024
2009359322
20100—322
20112—042
20120—024
20130—139
20142—04
20150—07
20161—016
20171—016
20182—034
20192—056
20200—034
20212—057
20220—09
20230—036
20240—034
20250—061
20261—0—

What is it indicated for?

The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Indications for use as stated in the FDA summary.

Also cleared against K003261

5 other devices cite the same predicate.

  • K073634Multigent Creatinine (Enzymatic) AssaySENTINEL CH. SpA · 20081 recall
  • K073055Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270Dade Behring, Inc. · 20085 recalls
  • K070383Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd. · 20072 recalls
  • K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007
  • K024098Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 20022 recalls

More from Siemens Healthcare Diagnostics, Inc.

281 FDA decisions under this applicant name. See the company

  • P930027/S041IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
  • P010007/S028IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026
  • P240021/S001Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026
  • P930027/S040IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
  • P010007/S027IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026

Recent decisions in JFY

The JFY category page

  • K252619Qscheck UisacrQstag, Inc. · 2026
  • K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc. · 2021
  • K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
  • K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019

https://510kreport.com/device/K090330 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090330: Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models K1270, KC270.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090330

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026