510(k) · Cleared
ClearedPersonallab Automated Microplate Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biochem Immunosystems (U.S.), Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jul 22, 1997 after a 71-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jul 22, 1997
- Review
- 71 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK971761 Personallab Automated Microplate AnalyzerBiochem Immunosystems (U.S.), Inc. · 1997
- Descendant · cites it directly · 2 of its ownK030404 C. Difficile Tox a/B IITechlab, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971761 | Personallab Automated Microplate Analyzer | Biochem Immunosystems (U.S.), Inc. | 1997 | — |
| +1 | K030404 | C. Difficile Tox a/B II | Techlab, Inc. | 2003 | — |
| +2 | K050891 | Tox a/B Quick Chek | Techlab, Inc. | 2005 | — |
| +2 | K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
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 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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030404 | C. Difficile Tox a/B II | 2003 | 2 |
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, K030404 (Techlab, Inc., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JJE devicesJJE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | 0 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
The PersonalLAB™ Automated Microplate Analyzer from BIOCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 98 well microplate formats, such as: e E.LA. (Enzyme Immuno Assay), and E.L.L.S.A. (Enzyme Linked Immuno Sorbent Assay). The PersonalLAB™ Automated Microplate…
Read the full statement (188 words)
The PersonalLAB™ Automated Microplate Analyzer from BIOCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 98 well microplate formats, such as:
e E.LA. (Enzyme Immuno Assay), and
E.L.L.S.A. (Enzyme Linked Immuno Sorbent Assay).
The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer’s Instructions For Use. The steps performed are as follows:
Specimen handling and identification,
Specimen pipetting and pre-dilution,
Reagent distribution and pipetting,
Washing of the microplates,
Incubation of the microplates,
Photometric reading of the microplates,
Data analysis - both quantitative and qualitative,
Data management — displaying, printing and archiving, and
Waste management.
The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows:
Whole blood,
Serum,
Plasma,
Urine,
Stool,
Spinal fluid,
Saliva, and
Swabs from antigen sites.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971761: Personallab Automated Microplate Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971761
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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