510(k) Report

510(k) · Cleared

Recalled · 2005

ELX808 Automated Microplate Readers

K953710510(k) TraditionalCleared Oct 25, 199577-day reviewClass I21 CFR 862.2300Recalls 1

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

Bio-Tek Instruments, Inc. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on Oct 25, 1995 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Oct 25, 1995
Review
77 days
Class
Class I
Product code
JJQ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953710 ELX808 Automated Microplate ReadersBio-Tek Instruments, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK102643 Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953710ELX808 Automated Microplate ReadersBio-Tek Instruments, Inc.1995—
+1K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K953710, 1995–2011Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJQ? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc.20110

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 15, 2005Not classifiedZ-0574-05OtherThe parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K102643 (Astoria-Pacific, Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJQ devices

JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJQ

FDA has decided no JJQ device since 2007.

Median 510(k) review, days · JJQ

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

Recalls per year · JJQ

1in 2025

2008: 22009: 12011: 12022: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JJQ

20in 2025

2007: 12008: 42009: 102010: 462011: 62012: 32013: 632014: 692015: 132016: 92017: 102018: 22019: 12021: 32022: 222023: 142024: 72025: 20
2007high 69 (2014) · low 0 (2020)2025

MAUDE reports naming product code JJQ, 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—01
20080—24
20090—110
20100—046
20110—16
20120—03
20130—063
20140—069
20150—013
20160—09
20170—010
20180—02
20190—01
20200—00
20210—03
20220—122
20230—014
20240—07
20250—120
20260—0—

More from Bio-Tek Instruments, Inc.

37 FDA decisions under this applicant name. See the company

  • K973609Ida-4 and Ipt-MCBio-Tek Instruments, Inc. · 1997
  • K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc. · 1997
  • K961862Models Ida-2 Plus and Ipt-1Bio-Tek Instruments, Inc. · 1997
  • K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load AdapterBio-Tek Instruments, Inc. · 1995
  • K953572ELX800UVBio-Tek Instruments, Inc. · 1995

Recent decisions in JJQ

The JJQ category page

  • K013371Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 20011 recall
  • K980120Digene DML 2000 Microplate LuminometerDigene Corp. · 19981 recall
  • K973938Alpha 4 LS Automated Microtiterplate Processor and ReaderSfri, Inc. · 1998
  • K974762Stat TracksAwareness Technology, Inc. · 1998
  • K962113Anthos Phacts Version Microplate ReaderColumbia Bioscience, Inc. · 1996

https://510kreport.com/device/K953710 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953710: ELX808 Automated Microplate Readers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953710

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026