510(k) Report

510(k) · Cleared

Recalled · 2009

Piccolo (TM)

K942782510(k) TraditionalCleared Mar 13, 1995273-day reviewClass I21 CFR 862.2140Recalls 1

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

Abaxis, Inc. · JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

Cleared on Mar 13, 1995 after a 273-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it. It has been recalled once.

Decided
Mar 13, 1995
Review
273 days
Class
Class I
Product code
JJG
Recalls
1
Predicates
0

10 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2008: 6 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK942782 Piccolo (TM)Abaxis, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK171971 Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer…Lite-On Technology Corp. H.S.P.B. · 2018
  3. Descendant · cites it directly · 1 of its ownK072140 S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc. · 2008
  4. Descendant · 2 generations on · 0 of its ownK251074 Tru Liver Health Test PanelTruvian Health · 2025
  5. Descendant · 2 generations on · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
  6. Descendant · 2 generations on · 0 of its ownK120369 Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc. · 2012

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 62012: 12018: 12025: 2
2008high 6 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Lite-On Technology Corp. H.S.P.B. · 2018 · cites it directly2descendants
  • K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc. · 2008 · cites it directly1descendant
  • K251074Tru Liver Health Test PanelTruvian Health · 2025 · 2 generations on0descendants
  • K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025 · 2 generations on0descendants
  • K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942782Piccolo (TM)Abaxis, Inc.1995—
+1K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare…Lite-On Technology Corp. H.S.P.B.2018—
+1K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.2008—
+2K251074Tru Liver Health Test PanelTruvian Health2025—
+2K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health2025—
+2K120369Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)Hitachi Chemical Diagnostics, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200860
201210
201810
202520
FIG. 1 — Lineage of K942782, 1995–2025Source: 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 JJG? 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
Get a 510(k) Report

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? (10)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Lite-On Technology Corp. H.S.P.B.20182
K072140S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test GluAlfa Wassermann Diagnostic Technologies, Inc.20081
K072143S40 Clinical Analyzer, S Test AlbAlfa Wassermann Diagnostic Technologies, Inc.20080
K073223S-Test C02Alfa Wassermann Diagnostic Technologies, Inc.20080
K072142S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test AstAlfa Wassermann Diagnostic Technologies, Inc.20080
K072141S40 Clinical Analyzer, S Test IP, S Test UAAlfa Wassermann Diagnostic Technologies, Inc.20080
K072356S-Test CAAlfa Wassermann Diagnostic Technologies, Inc.20080

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 16, 2009Not classifiedZ-1155-2010Labeling mix-upsWrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K171971 (Lite-On Technology Corp. H.S.P.B., 2018) has gone furthest, with 2 descendants of its own.

How does its category compare?

All JJG devices

JJG Analyzer, Chemistry, Centrifugal, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJG

FDA has decided no JJG device since 2007.

Median 510(k) review, days · JJG

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

Recalls per year · JJG

No recall names JJG since 2007.

Adverse event reports per year · JJG

5in 2025

2008: 12009: 12012: 12015: 12018: 12020: 862021: 122022: 42023: 52024: 42025: 5
2007high 86 (2020) · low 0 (2007)2025

MAUDE reports naming product code JJG, 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—00
20080—01
20090—01
20100—00
20110—00
20120—01
20130—00
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—086
20210—012
20220—04
20230—05
20240—04
20250—05
20260—0—

More from Abaxis, Inc.

20 FDA decisions under this applicant name. See the company

  • K200865Piccolo Potassium Test SystemAbaxis, Inc. · 2021
  • K130113Piccolo Lactate Test SystemAbaxis, Inc. · 2013
  • K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013
  • K120664Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012
  • K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc. · 2012

Recent decisions in JJG

The JJG category page

  • K972409AG Chemistry Analyzer SystemLandmark Scientific, Inc. · 1997
  • K934592Epoc 2000 Point-of-Care Analyzer and Epoc 5-Chemistry Reagent RotorAbaxis, Inc. · 19941 recall
  • K920942Olympus AU800 Clinical Chemistry AnalyzerOlympus Corp. · 1992
  • K910222Cobas AlphaRoche Diagnostic Systems, Inc. · 1991
  • K903626Biomek Automated Laboratory Workstation W/GenelisaBeckman Instruments, Inc. · 1990

https://510kreport.com/device/K942782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942782: Piccolo (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942782

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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