510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)

K013596510(k) TraditionalCleared May 16, 2002197-day reviewClass II21 CFR 864.5700Recalls 2

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

Accumetrics, Inc. · JOZ System, Automated Platelet Aggregation

Cleared on May 16, 2002 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) and 1 other predicate after a 197-day review. Its family tree reaches back 1 generation to 1976. It has been recalled 2 times.

Decided
May 16, 2002
Review
197 days
Class
Class II
Product code
JOZ
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K760198 (1976). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1983: 1 other ancestorK760198 · Kit, Platelet Aggregation Reagent (#390) · Chrono-Log Corp. · 1976197519801985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K760198 · Kit, Platelet Aggregation Reagent (#390) · Chrono-Log Corp. · 19760
  1. Root · 1 generation backK760198 Kit, Platelet Aggregation Reagent (#390)Chrono-Log Corp. · 1976
  2. This deviceK013596 Modification to Ultegra System Rapid Platelet Function Assay - Trap…Accumetrics, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760198Kit, Platelet Aggregation Reagent (#390)Chrono-Log Corp.1976—
0 (this device)K013596Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)Accumetrics, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
FIG. 1 — Lineage of K013596, 1976–2002Source: 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), 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 JOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOZ device

  1. #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.6 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K830749Platelet Aggregometer
Summary page 1
…ccumetrics Ultegra System Analyzer and Rapid Platelet Function Assay have been found to be substantially equivalent to CHRONO-LOG Corporation’s Whole Blood Aggregometer (K830749) and CHRONO-PAR Reagent (K760198). Device Description: The Ultegra System is a turbidimetric based optical detection system whi…
Chrono-Log Corp.1983—
*K760198Kit, Platelet Aggregation Reagent (#390)
Summary page 1
…r and Rapid Platelet Function Assay have been found to be substantially equivalent to CHRONO-LOG Corporation’s Whole Blood Aggregometer (K830749) and CHRONO-PAR Reagent (K760198). Device Description: The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggr…
Chrono-Log Corp.1976—

Also cleared against K830749: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 13, 2014Class IIZ-1172-2014Nonconforming Material/ComponentAccumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low…
Nov 14, 2013Class IIZ-0482-2014OtherAccumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 8 other devices also cite its predicate K830749.

How does its category compare?

All JOZ devices

JOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOZ

1in 2020

2012: 12013: 12015: 22016: 12017: 12019: 12020: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOZ

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

Recalls per year · JOZ

1in 2025

2013: 12024: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JOZ

3in 2025

2010: 12012: 12013: 12014: 12017: 12018: 252019: 92020: 22021: 22022: 162024: 12025: 3
2007high 25 (2018) · low 0 (2007)2025

MAUDE reports naming product code JOZ, 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—00
20090—00
20100—01
20110—00
20121—01
20131—11
20140—01
20152—00
20161—00
20171—01
20180—025
20191—09
20201—02
20210—02
20220—016
20230—00
20240—11
20250—13
20260—0—

What is it indicated for?

The Ultegra Rapid Platelet Function Assay - TRAP (RPFA -TRAP) is a semi-quantitative whole blood platelet function assay used to measure glycoprotein

(GP) lIb/llla receptor blockade in patients treated with abciximab or eptifibatide.

Ultegra RPFA-TRAP results should be interpreted in conjunction with other

clinical and laboratory data available to the clinician.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K830749

8 other devices cite the same predicate.

  • K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
  • K051231Verifynow-P2Y12 AssayAccumetrics, Inc. · 20053 recalls
  • K042423Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
  • K012701Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc. · 20021 recall
  • K992531Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System Rpfa-Trap Level One QC…Accumetrics, Inc. · 19993 recalls
  • K990398PlateletworksArray Medical, Inc. · 1999

More from Accumetrics, Inc.

7 FDA decisions under this applicant name. See the company

  • K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc. · 20152 recalls
  • K051231Verifynow-P2Y12 AssayAccumetrics, Inc. · 20053 recalls
  • K042423Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
  • K012701Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc. · 20021 recall
  • K011337Ultegra System Rapid Platelet Function Assay (Rpfa)Accumetrics, Inc. · 20012 recalls

Recent decisions in JOZ

The JOZ category page

  • K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set…Fujimori Kogyo, Co., Ltd. · 2020
  • K181777AggreGuide A-100 ADPAggredyne, Inc. · 20191 recall
  • K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 20171 recall
  • K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016
  • K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc. · 20152 recalls

https://510kreport.com/device/K013596 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013596: Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013596

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026