510(k) Report

510(k) · Cleared

Recalled · 2010

DSL I-PTH (DSL #8000)

K896294510(k) TraditionalCleared Nov 21, 198921-day reviewClass II21 CFR 862.1545Recalls 1

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

Diagnostic Systems Laboratories, Inc. · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Nov 21, 1989 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Nov 21, 1989
Review
21 days
Class
Class II
Product code
CEW
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1990200020102020
  1. This deviceK896294 DSL I-PTH (DSL #8000)Diagnostic Systems Laboratories, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK020945 Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896294DSL I-PTH (DSL #8000)Diagnostic Systems Laboratories, Inc.1989—
+1K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K896294, 1989–2002Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CEW? 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 CEW device

  1. #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc.20020

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 22, 2010Not classifiedZ-0585-2011PendingThe recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020945 (Diagnostic Systems Laboratories, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CEW devices

CEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEW

2in 2024

2007: 42010: 12012: 12013: 22014: 12015: 12017: 22019: 12023: 12024: 2
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEW

160in 2007

2007: 160 days median
2007high 160 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CEW

1in 2025

2007: 12008: 12010: 32013: 12016: 22022: 22024: 22025: 1
2007high 3 (2010) · low 0 (2009)2026

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

Adverse event reports per year · CEW

37in 2025

2008: 82009: 42010: 232011: 972012: 1242013: 1722014: 1672015: 572016: 982017: 832018: 652019: 772020: 502021: 572022: 1882023: 822024: 672025: 37
2007high 188 (2022) · low 0 (2007)2025

MAUDE reports naming product code CEW, 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
2007416010
20080—18
20090—04
20101—323
20110—097
20121—0124
20132—1172
20141—0167
20151—057
20160—298
20172—083
20180—065
20191—077
20200—050
20210—057
20220—2188
20231—082
20242—267
20250—137
20260—0—

More from Diagnostic Systems Laboratories, Inc.

94 FDA decisions under this applicant name. See the company

  • K061758Active Renin IrmaDiagnostic Systems Laboratories, Inc. · 2006
  • K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002
  • K020128Active Free Beta-HCG Elisa, Model DSL-10-8500Diagnostic Systems Laboratories, Inc. · 2002
  • K002128Active Inhibin-a Elisa, Model DSL-10-28100Diagnostic Systems Laboratories, Inc. · 20004 recalls
  • K001086Free Testosterone Enzyme Immunoassay, Model DSL-10-4900Diagnostic Systems Laboratories, Inc. · 2000

Recent decisions in CEW

The CEW category page

  • K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics · 2024
  • K232791Access Intact PTHBeckman Coulter, Inc. · 20241 recall
  • K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics · 2023
  • K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019
  • K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K896294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896294: DSL I-PTH (DSL #8000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896294

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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