510(k) · Cleared
ClearedStasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wortham Laboratories, Inc. · GIZ Plasma, Control, Normal
Cleared on May 15, 2007 as substantially equivalent to K984129 (Pacific Hemostasis, 1998) and 10 other predicates after a 403-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- May 15, 2007
- Review
- 403 days
- Class
- Class II
- Product code
- GIZ
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 2 generations to K771346 (1977). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK771346 CI-Trol Coagulation Controls II & IiiDade, Baxter Travenol Diagnostics, Inc. · 1977
- 1 generation backK984130 Coagulation Control Level 2 (Abnormal)Pacific Hemostasis · 1998
- This deviceK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771346 | CI-Trol Coagulation Controls II & Iii | Dade, Baxter Travenol Diagnostics, Inc. | 1977 | — |
| −1 | K984130 | Coagulation Control Level 2 (Abnormal) | Pacific Hemostasis | 1998 | — |
| 0 (this device) | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
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 GIZ? 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
What was it cleared against? (11)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984129 | Coagulation Control Level 1 (Normal)Summary page 1…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Coagulation Control Level I (K984129) Description Wortham Laboratories Stasis I Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healt… | 1998 |
| * | K984130 | Coagulation Control Level 2 (Abnormal)Summary page 4…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Coagulation Control Level !! (K984130) Description Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from hea… | 1998 |
| * | K984131 | Coagulation Control Level 3 (Abnormal)Summary page 7…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Coagulation Control Level III (K984131) Description Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from hea… | 1998 |
| * | K994100 | Pacific Hemostasis Thromboplastin DSummary page 10…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Thromboplastin-D (K994100) Description Worthamn Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calciu… | 2000 |
| * | K940082 | Thromboscreen Thromboplastin-DSSummary page 13…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Thromboplastin-DS (K940082) Description Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium… | 1995 |
| * | K891337 | Thromboscreen Aptt ReagentSummary page 16…cal use in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis APTT-LS (K891337) Description Worthanm Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin… | 1989 |
| * | K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinSummary page 19…cal use in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Kontact (K023362) Description Wortham Laboratories Intrin-SI APTT reagent is intended for use in determining activated partial thromboplaslin t… | 2002 |
| * | K800826 | Fibrinogen ScreenSummary page 22…in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Fibrinogen Assay (K800826) Description Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healt… | 1980 |
| * | K970645 | BC Thrombin ReagentSummary page 26…se in conjunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Thrombin Reagent (K970645) Description Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine prothrombin proteins (Fa… | 1997 |
| * | K992278 | Heparin Control Plasma Level 1Summary page 28…njunction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Heparin Control Level I (K992278) Description Wortham Laboratories Heparin Control Level I is a liquid stable preparation of citrated plasma obtained from heal… | 1999 |
| * | K992279 | Heparin Control Plasma Level 2Summary page 30…junction with an analyzer to measure clot formation. Predicate: Pacific Hemostasis Heparin Control Level 11(K992279) Desiription Wortharn Laboratories Ileparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from he… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 21.3 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All GIZ devicesGIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GIZ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GIZ
Too few GIZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GIZ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIZ
No MAUDE report names GIZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Wortham Laboratories Stasis I Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range. Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated…
Read the full statement (476 words)
Wortham Laboratories Stasis I Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Worthamt Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing, for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mng/dl), Thrombin Reagent (100 IU/mi), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Worthamn Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaC1 2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060968
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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