FDA product code JGY: Colorimetric Method, Triglycerides
JGY is the FDA product code for colorimetric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel. FDA has cleared 22 510(k) submissions under JGY, from 19 different applicants. The average 510(k) review took 79 days (median 48). FDA has posted 2 recalls for JGY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric Method, Triglycerides |
| Device class | Class I |
| Regulation | 21 CFR 862.1705 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGY clearance
Top JGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abaxis, Inc. | 2 | 2012-04-24 |
| Polymer Technology Systems, Inc. | 2 | 2000-07-03 |
| Data Medical Associates, Inc. | 2 | 1994-07-20 |
| Derma Media Lab., Inc. | 1 | 1997-04-21 |
| Schiapparelli Biosystems, Inc. | 1 | 1995-10-23 |
14 more applicants have JGY clearances. See the full list in Caduvo.
Most recent JGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120664 | Abaxis, Inc. | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | 2012-04-24 | 50 |
| K023639 | Abaxis, Inc. | PICCOLO TRIGLYCERIDES TEST SYSTEM | 2003-01-24 | 86 |
| K000586 | Polymer Technology Systems, Inc. | BIOSCANNER TRIGLYCERIDES TEST STRIPS | 2000-07-03 | 132 |
| K991894 | Polymer Technology Systems, Inc. | BIOSCANNER TRIGLYCERIDES TEST STRIPS | 2000-05-24 | 356 |
| K971005 | Derma Media Lab., Inc. | TRIGLYCERIDES | 1997-04-21 | 33 |
Recalls for JGY devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code JGY?
JGY is the FDA product code for colorimetric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel.
What device class is JGY?
Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGY?
Across 22 cleared submissions the average was 79 days from receipt to decision (median 48).
Which companies have the most JGY clearances?
Abaxis, Inc. (2); Polymer Technology Systems, Inc. (2); Data Medical Associates, Inc. (2); Derma Media Lab., Inc. (1); Schiapparelli Biosystems, Inc. (1).
Have JGY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JGY
- Run a recall and safety report across every JGY manufacturer
- Watch product code JGY 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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