510(k) Report

510(k) · Cleared

Cleared

Sas Adeno Test

K990630510(k) TraditionalCleared Aug 19, 1999174-day reviewClass I21 CFR 866.3020

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

Sa Scientific, Inc. · GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33

Cleared on Aug 19, 1999 after a 174-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Aug 19, 1999
Review
174 days
Class
Class I
Product code
GOD
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990630 Sas Adeno TestSa Scientific, Inc. · 1999
  2. Descendant · cites it directly · 1 of its ownK052092 RPS Adeno DetectorRapid Pathogen Screening · 2005
  3. Descendant · 2 generations on · 0 of its ownK110722 RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K052092RPS Adeno DetectorRapid Pathogen Screening · 2005 · cites it directly1descendant
  • K110722RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990630Sas Adeno TestSa Scientific, Inc.1999—
+1K052092RPS Adeno DetectorRapid Pathogen Screening2005—
+2K110722RPS Adeno Detector PlusRapid Pathogen Screening, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201110
FIG. 1 — Lineage of K990630, 1999–2011Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GOD? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K052092RPS Adeno DetectorRapid Pathogen Screening20051

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?

  • Of its descendants, K052092 (Rapid Pathogen Screening, 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GOD devices

GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GOD

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GOD

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

Recalls per year · GOD

No recall names GOD since 2007.

Adverse event reports per year · GOD

No MAUDE report names GOD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The SAS™ Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Sa Scientific, Inc.

199 FDA decisions under this applicant name. See the company

  • K100227Sas Flualert a&B, Sas Influenza a TestSa Scientific, Inc. · 2010
  • K080380Sas Influenza a & B TestSa Scientific, Inc. · 2009
  • K041439Sas Influenza B TestSa Scientific, Inc. · 2004
  • K041441Sas Influenza a TestSa Scientific, Inc. · 2004
  • K030628Sas RSV Control KitSa Scientific, Inc. · 2003

Recent decisions in GOD

The GOD category page

  • K110722RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011
  • K052092RPS Adeno DetectorRapid Pathogen Screening · 2005
  • K972406Adenovirus Antigen Detection Elisa Test SystemImmunoprobe, Inc. · 1997
  • K881894Adenoclone (R)-Type 40/41 Eia Diagnostic Test (48)Cambridge Bioscience Corp. · 1988
  • K873082Adenoclone (TM)-Eia Adenovirus Antigen TestCambridge Bioscience Corp. · 1988

https://510kreport.com/device/K990630 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990630: Sas Adeno Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990630

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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