FDA product code · Hematology
GGPTest, Qualitative And Quantitative Factor Deficiency
Product code GGP covers Test, Qualitative And Quantitative Factor Deficiency, a Class II device regulated under 21 CFR 864.7290. FDA has cleared 190 devices in this code, 1 of them in the last 12 months. Median review time across the 190 most recent decisions is 71 days. openFDA lists 13 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 864.7290
- Review panel
- Hematology
- Clearances
- 190
What is happening in GGP right now?
GGP (Test, Qualitative And Quantitative Factor Deficiency) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1491-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1491-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in GGP?
FDA has cleared 190 devices under product code GGP since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | |
| K181525 | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | |
| K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | Instrumentation Laboratory CO |
How long does FDA review take for GGP?
The median FDA review time for GGP is 71 days, measured across the 190 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GGP?
openFDA lists 13 recall records against product code GGP. A recall record covers one firm's corrective action and may span many device lots.
Z-1491-2026Open, ClassifiedDiagnostica Stago, Inc.
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Z-1227-2023Open, ClassifiedAniara Diagnostica LLC
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
Z-1699-2020TerminatedDiagnostica Stago, Inc.
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
Z-0106-2019TerminatedHelena Laboratories, Corp.
Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
Z-0736-2016TerminatedInstrumentation Laboratory
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Showing the 5 most recently initiated of 13. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GGP?
MAUDE holds 3 adverse-event reports naming product code GGP, 2 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GGP unusual?
GGP does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
2 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in GGP?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GGP?
Across the 190 most recent decisions, these applicants filed most often in GGP.
| Applicant | Recent clearances |
|---|---|
| Instrumentation Laboratory CO | 27 |
| American Bioproducts Co. | 22 |
| Helena Laboratories | 17 |
| American Dade | 9 |
| Biopool AB | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in GGP files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Instrumentation Laboratory | 28 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GGP
Get an email the morning anything changes in GGP — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.