510(k) Report

510(k) · Cleared

Cleared

Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/

K970505510(k) TraditionalCleared Nov 17, 1997280-day reviewClass II21 CFR 864.5700

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

Dade Intl., Inc. · JOZ System, Automated Platelet Aggregation

Cleared on Nov 17, 1997 as substantially equivalent to K771198 (Chrono-Log Corp., 1977) and 2 other predicates after a 280-day review. Its family tree reaches back 1 generation to 1977. 2 later devices descend from it.

Decided
Nov 17, 1997
Review
280 days
Class
Class II
Product code
JOZ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K771198 (1977). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1985: 1 other ancestor1983: 1 other ancestor2006: 1 descendant cleared2020: 1 descendant clearedReference device: K922800 · Platelet Aggregation Reagents · Chrono-Log Corp. · 1992K771198 · Lumi-Aggregometer · Chrono-Log Corp. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K771198 · Lumi-Aggregometer · Chrono-Log Corp. · 19770
  1. Root · 1 generation backK771198 Lumi-AggregometerChrono-Log Corp. · 1977
  2. This deviceK970505 Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine…Dade Intl., Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK060489 Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 0 of its ownK191364 T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL…Fujimori Kogyo, Co., Ltd. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006 · cites it directly1descendant
  • K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K771198Lumi-AggregometerChrono-Log Corp.1977—
0 (this device)K970505Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test…Dade Intl., Inc.1997—
+1K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc.2006—
+2K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for…Fujimori Kogyo, Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
202010
FIG. 1 — Lineage of K970505, 1977–2020Source: 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? (3)

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
*K771198Lumi-Aggregometer
Summary page 1
…equivalent in intended use to the Chrono-log Aggregometer, manufactured by Chrono-log Corporation, Haverton, PA, that was previously cleared under Document Control Nos. K771198, K830749 and K851025. The associated Chrono-log aggregation reagents were most recently cleared under Document Control No. K92280…
Chrono-Log Corp.1977—
*K830749Platelet Aggregometer
Summary page 1
…nt in intended use to the Chrono-log Aggregometer, manufactured by Chrono-log Corporation, Haverton, PA, that was previously cleared under Document Control Nos. K771198, K830749 and K851025. The associated Chrono-log aggregation reagents were most recently cleared under Document Control No. K922800. The D…
Chrono-Log Corp.1983—
*K851025Aggro/Link Computer Interface
Summary page 1
…ed use to the Chrono-log Aggregometer, manufactured by Chrono-log Corporation, Haverton, PA, that was previously cleared under Document Control Nos. K771198, K830749 and K851025. The associated Chrono-log aggregation reagents were most recently cleared under Document Control No. K922800. The Dade® PFA-100…
Chrono-Log Corp.1985—
†K922800Platelet Aggregation ReagentsChrono-Log Corp.1992—

Also cleared against K771198: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K060489Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc.20061

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K060489 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K771198.

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?

To aid in the detection of platelet dysfunction in citrated human

whole blood for use in patients with a suspected disorder of

primary hemostasis.

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 K771198

1 other device cites the same predicate.

  • K990398PlateletworksArray Medical, Inc. · 1999

More from Dade Intl., Inc.

58 FDA decisions under this applicant name. See the company

  • P870049/S032Microscan Rapid Gram Positive Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S031Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S030Microscan (R) Rapid Fluorogenic PanelsDade Intl., Inc. · 2000
  • P870049/S029Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999
  • P870049/S028Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999

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/K970505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970505: Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa Collagen/Adp Test Cartridge/.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970505

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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