510(k) · Cleared

Cleared

Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator

K080662510(k) TraditionalCleared May 15, 200866-day reviewClass II21 CFR 862.1225

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

Genzyme Corporation · NDY Test, Cystatin C

Cleared on May 15, 2008 as substantially equivalent to K041878 (Dade Behring, Inc., 2004) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 2001.

Decided: May 15, 2008
Review: 66 days
Class: Class II
Product code: NDY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K003503 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003503 N Latex Cystatin CDade Behring, Inc. · 2001
1 generation backK041878 N Latex CystatinDade Behring, Inc. · 2004
This deviceK080662 Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003503	N Latex Cystatin C	Dade Behring, Inc.	2001	—
−1	K041878	N Latex Cystatin	Dade Behring, Inc.	2004	—
0 (this device)	K080662	Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator	Genzyme Corporation	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K080662, 2001–2008Source: 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 NDY? 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 NDY device

#1 K242585 Cystatin Cscore 10.6 · 5 generations · no Class I recall

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K041878	N Latex Cystatin Summary page 1 …Calibrator, Secondary 3. Identification of the Legally Marketed Device: Dade Behring N Latex Cystatin C - k041878 Dade Behring N Protein Standard UY, calibrator - k003501 4. Device Description: Genzyme Cystatin C assay re…	Dade Behring, Inc.	2004	—
*	K003501	N Protein Standard UY Calibrator Summary page 1 …ndary 3. Identification of the Legally Marketed Device: Dade Behring N Latex Cystatin C - k041878 Dade Behring N Protein Standard UY, calibrator - k003501 4. Device Description: Genzyme Cystatin C assay reagent is based on the sol particle turbidimetric immunoass…	Dade Behring, Inc.	2001	—

Also cleared against K041878: 2 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K041878.

How does its category compare?

All NDY devices

NDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NDY

1in 2025

2007high 6 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDY

265in 2010

2007high 265 (2010) · low 95 (2007)2026

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

Recalls per year · NDY

1in 2020

2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · NDY

10in 2025

2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code NDY, 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	3	95	0	0
2008	6	101	0	0
2009	1	—	0	0
2010	3	265	0	0
2011	0	—	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	1	—	0	0
2015	0	—	0	1
2016	1	—	0	1
2017	1	—	0	2
2018	1	—	0	0
2019	0	—	0	1
2020	0	—	1	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	2
2024	0	—	0	3
2025	1	—	0	10
2026	0	—	0	—

What is it indicated for?

For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases.

For In Vitro Diagnostic Use.

For the calibration of Genzyme Cystatin C assay.

For In Vitro Diagnostic Use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080662 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080662: Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080662

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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