510(k) Report

510(k) · Cleared

Cleared

Immunocyt

K994356510(k) TraditionalCleared Feb 23, 200062-day reviewClass II21 CFR 864.1860

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

Diagnocure, Inc. · NBK System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Cleared on Feb 23, 2000 as substantially equivalent to K964151 (Bard Diagnostic Sciences,Inc., 1997) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1997.

Decided
Feb 23, 2000
Review
62 days
Class
Class II
Product code
NBK
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K964151 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorK964151 · Bard and Bta Test · Bard Diagnostic Sciences,Inc. · 19971996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor K964151 · Bard and Bta Test · Bard Diagnostic Sciences,Inc. · 19970
  1. Root · 1 generation backK964151 Bard and Bta TestBard Diagnostic Sciences,Inc. · 1997
  2. This deviceK994356 ImmunocytDiagnocure, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964151Bard and Bta TestBard Diagnostic Sciences,Inc.1997—
0 (this device)K994356ImmunocytDiagnocure, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K994356, 1997–2000Source: 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 NBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K964151Bard and Bta Test
Summary page 1
…k) Number: #2 Predicate Device: Manufacturer: Applicant: 510(k) Number: Bard BTA stat Test Bainbridge Sciences Inc., Subsidiary of C.R. Bard Inc. Redmond, Washington K964151 Auratek FDP Organon Teknika, B.V. Perimmune Inc. 1330 Piccard Dr. Rockville, MD 20850 K970353 Note: Auratek FDP js marketed in…
Bard Diagnostic Sciences,Inc.1997—
*K970353Aura Tek FDP
Summary page 1
…ainbridge Sciences Inc., Subsidiary of C.R. Bard Inc. Redmond, Washington K964151 Auratek FDP Organon Teknika, B.V. Perimmune Inc. 1330 Piccard Dr. Rockville, MD 20850 K970353 Note: Auratek FDP js marketed in the US under the name Accu-Dx Premarket Notification ImmunoCyt Page 58 D. Dev…
Perimmune, Inc.1997—

Also cleared against K964151: 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?

  • None of the 2 ancestors has a recall.
  • 2 other devices also cite its predicate K964151.

How does its category compare?

All NBK devices

NBK System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NBK

FDA has decided no NBK device since 2007.

Median 510(k) review, days · NBK

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

Recalls per year · NBK

No recall names NBK since 2007.

Adverse event reports per year · NBK

1in 2021

2017: 42021: 1
2007high 4 (2017) · low 0 (2007)2025

MAUDE reports naming product code NBK, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—04
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumor cells exfoliated in the urine of patients previously diagnosed with bladder cancer. ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.

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

Also cleared against K964151

2 other devices cite the same predicate.

  • K974845Bta Stat Test Prescription Home UseBard Diagnostic Sciences,Inc. · 1998
  • K971402Bard Bta Trak TestBard Diagnostic Sciences,Inc. · 1998

https://510kreport.com/device/K994356 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994356: Immunocyt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994356

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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