510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Atac 8000 Random Access Chemistry System

K945271510(k) TraditionalCleared Apr 20, 1995184-day reviewClass I21 CFR 862.2160Recalls 1

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

Bio-Chem Laboratory Systems, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Cleared on Apr 20, 1995 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided
Apr 20, 1995
Review
184 days
Class
Class I
Product code
JJE
Recalls
1
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK945271 Atac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK121027 Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc. · 2012
  3. Descendant · 2 generations on · 0 of its ownK133751 Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise…Diamond Diagnostics, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc. · 2012 · cites it directly1descendant
  • K133751Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsDiamond Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945271Atac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc.1995—
+1K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc.2012—
+2K133751Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsDiamond Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
FIG. 1 — Lineage of K945271, 1995–2014Source: 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 JJE? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc.20121

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 18, 2017Class IIZ-2591-2018Under Investigation by firmELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K121027 (Diamond Diagnostics, Inc., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJE devices

JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJE

1in 2019

2008: 12011: 22012: 12013: 12014: 32019: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJE

224in 2014

2014: 224 days median
2007high 224 (2014)2026

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

Recalls per year · JJE

6in 2025

2007: 202008: 202009: 142010: 322011: 252012: 162013: 212014: 142015: 152016: 92017: 182018: 172019: 72020: 72021: 62023: 122024: 62025: 62026 (partial year): 5
2007high 32 (2010) · low 0 (2022)2026

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

Adverse event reports per year · JJE

4,400in 2025

2007: 2,1812008: 2,1592009: 3,4402010: 3,2732011: 11,6062012: 3,7072013: 2,4892014: 2,8412015: 2,7932016: 2,5802017: 1,8692018: 4,5902019: 3,9482020: 3,9862021: 3,9202022: 3,9982023: 3,7832024: 4,2212025: 4,400
2007high 11,606 (2011) · low 1,869 (2017)2025

MAUDE reports naming product code JJE, 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—202,181
20081—202,159
20090—143,440
20100—323,273
20112—2511,606
20121—163,707
20131—212,489
20143224142,841
20150—152,793
20160—92,580
20170—181,869
20180—174,590
20191—73,948
20200—73,986
20210—63,920
20220—03,998
20230—123,783
20240—64,221
20250—64,400
20260—5—

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The JJE category page

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https://510kreport.com/device/K945271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945271: Atac 8000 Random Access Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945271

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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