# K971761: Personallab Automated Microplate Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Biochem Immunosystems (U.S.), Inc.
- Decided: Jul 22, 1997 after 71 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030404: C. Difficile Tox a/B II (2003), 2 descendants of its own
- K050891: Tox a/B Quick Chek (2005), 1 descendant of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K971761
Methodology: https://510kreport.com/methodology