510(k) Report

510(k) · Cleared

Cleared

Stratus Myoglobin Gluorometric Enzyme Immunoassay

K965213510(k) TraditionalCleared Feb 10, 199742-day reviewClass II21 CFR 866.5680

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

Dade Intl., Inc. · DDR Myoglobin, Antigen, Antiserum, Control

Cleared on Feb 10, 1997 as substantially equivalent to K922125 (Baxter Diagnostics, Inc., 1992) after a 42-day review. Its family tree reaches back 1 generation to 1992.

Decided
Feb 10, 1997
Review
42 days
Class
Class II
Product code
DDR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K922125 (1992). No later device cites it as a predicate yet.

K922125 · Stratus Myoglobin Fluorometric Enzyme Immunoassay · Baxter Diagnostics, Inc. · 199219901992199419961998
K922125 · Stratus Myoglobin Fluorometric Enzyme Immunoassay · Baxter Diagnostics, Inc. · 19920
  1. Root · 1 generation backK922125 Stratus Myoglobin Fluorometric Enzyme ImmunoassayBaxter Diagnostics, Inc. · 1992
  2. This deviceK965213 Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922125Stratus Myoglobin Fluorometric Enzyme ImmunoassayBaxter Diagnostics, Inc.1992—
0 (this device)K965213Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc.1997—
FIG. 1 — Lineage of K965213, 1992–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DDR? 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 DDR device

  1. #1 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

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
*K922125Stratus Myoglobin Fluorometric Enzyme Immunoassay
Summary page 1
…ics to the current Stratus® Myoglobin Fluorometric Enzyme Immunoassay, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K922125/A. The proposed device is being modified to include heparinized plasma as a sample type. During an in-house comparative perform…
Baxter Diagnostics, Inc.1992—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All DDR devices

DDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DDR

1in 2023

2009: 22012: 12013: 12023: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DDR

Too few DDR 510(k)s in any year since 2007 to give a median.

Recalls per year · DDR

2in 2015

2007: 22009: 12015: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DDR

5in 2025

2009: 32011: 52012: 22013: 32014: 12016: 32017: 52018: 32019: 62020: 22021: 12022: 12023: 72024: 312025: 5
2007high 31 (2024) · low 0 (2007)2025

MAUDE reports naming product code DDR, 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
20070—20
20080—00
20092—13
20100—00
20110—05
20121—02
20131—03
20140—01
20150—20
20160—03
20170—05
20180—03
20190—06
20200—02
20210—01
20220—01
20231—07
20240—031
20250—05
20260—0—

More from Dade Intl., Inc.

58 FDA decisions under this applicant name. See the company

  • P870049/S032Microscan Rapid Gram Positive Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S031Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S030Microscan (R) Rapid Fluorogenic PanelsDade Intl., Inc. · 2000
  • P870049/S029Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999
  • P870049/S028Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999

Recent decisions in DDR

The DDR category page

  • K231832Access MyoglobinBeckman Coulter, Inc. · 2023
  • K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
  • K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 20121 recall
  • K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
  • K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc. · 2009

https://510kreport.com/device/K965213 · printed Nov 6, 2026

Cite this page

510(k) Report. “K965213: Stratus Myoglobin Gluorometric Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965213

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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