FDA product code JIY: Photometric Method, Iron (Non-Heme)
JIY is the FDA product code for photometric method, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel. FDA has cleared 67 510(k) submissions under JIY, from 47 different applicants. The average 510(k) review took 62 days (median 44). FDA has posted 19 recalls for JIY devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Photometric Method, Iron (Non-Heme) |
| Device class | Class I |
| Regulation | 21 CFR 862.1410 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-12-16 |
| Data Medical Associates, Inc. | 5 | 1994-11-15 |
| Dade Behring, Inc. | 2 | 2006-08-07 |
| Diagnostic Chemicals , Ltd. | 2 | 2002-05-14 |
| Pointe Scientific, Inc., | 2 | 1996-11-18 |
42 more applicants have JIY clearances. See the full list in Caduvo.
Most recent JIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061793 | Dade Behring, Inc. | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | 2006-08-07 | 42 |
| K060264 | Dade Behring, Inc. | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | 2006-03-08 | 35 |
| K051115 | Sentinel Ch. Srl | SENTINEL IRON LIQUID | 2005-08-25 | 115 |
| K033983 | Clinical Data, Inc. | VITALAB IRON REAGENT | 2004-05-21 | 150 |
| K030528 | Clinical Data | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | 2003-06-17 | 118 |
Recalls for JIY devices
19 product recalls in 10 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JIY?
JIY is the FDA product code for photometric method, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel.
What device class is JIY?
Class I, regulation 21 CFR 862.1410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIY?
Across 67 cleared submissions the average was 62 days from receipt to decision (median 44).
Which companies have the most JIY clearances?
Em Diagnostic Systems, Inc. (7); Data Medical Associates, Inc. (5); Dade Behring, Inc. (2); Diagnostic Chemicals , Ltd. (2); Pointe Scientific, Inc., (2).
Have JIY devices been recalled?
Yes: 19 product recalls across 10 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JIY
- Run a recall and safety report across every JIY manufacturer
- Watch product code JIY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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