510(k) · Cleared

Recalled · 2006

Stratus (R) CS Myoglobin (Myo) Testpak

K984065510(k) TraditionalCleared Dec 14, 199828-day reviewClass II21 CFR 866.5680Recalls 2

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

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

Cleared on Dec 14, 1998 as substantially equivalent to K981102 (Dade Behring, Inc., 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 2 times.

Decided: Dec 14, 1998
Review: 28 days
Class: Class II
Product code: DDR
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K981102 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981102 Stratus CS Myoglobin (Myo) TestpakDade Behring, Inc. · 1998
This deviceK984065 Stratus (R) CS Myoglobin (Myo) TestpakDade Behring, Inc. · 1998
Descendant · cites it directly · 0 of its ownK051650 Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test…Dade Behring, Inc. · 2005 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…Dade Behring, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981102	Stratus CS Myoglobin (Myo) Testpak	Dade Behring, Inc.	1998	—
0 (this device)	K984065	Stratus (R) CS Myoglobin (Myo) Testpak	Dade Behring, Inc.	1998	—
+1	K051650	Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus…	Dade Behring, Inc.	2005	11

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K984065, 1998–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K981102	Stratus CS Myoglobin (Myo) Testpak Summary page 1 …/6/98 Device Name: Stratus® CS Myoglobin (MYQO) TestPak Classification Name: Myoglobin Immunological Test System Predicate Device: Stratus® CS Myoglobin (MYO) TestPak (K981102) Device Description: The MYO TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper emb…	Dade Behring, Inc.	1998	—

Also cleared against K981102: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051650	Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…	Dade Behring, Inc.	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 3, 2006	Not classified	Z-0878-06	Other	Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the…
Apr 3, 2006	Not classified	Z-0884-06	Other	Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K051650 (Dade Behring, Inc., 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K981102.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	0
2008	0	—	0	0
2009	2	—	1	3
2010	0	—	0	0
2011	0	—	0	5
2012	1	—	0	2
2013	1	—	0	3
2014	0	—	0	1
2015	0	—	2	0
2016	0	—	0	3
2017	0	—	0	5
2018	0	—	0	3
2019	0	—	0	6
2020	0	—	0	2
2021	0	—	0	1
2022	0	—	0	1
2023	1	—	0	7
2024	0	—	0	31
2025	0	—	0	5
2026	0	—	0	—

What is it indicated for?

The MYO TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of Myoglobin in heparinized plasma. Measurements of Myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984065: Stratus (R) CS Myoglobin (Myo) Testpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984065

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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