OLDClass I

Internal Polymerase Chain Reaction Control, Not Assay Specific

21 CFR 862.1660 / Clinical Chemistry

OLD is the FDA product code for Internal Polymerase Chain Reaction Control, Not Assay Specific, a class I device type, regulated under 21 CFR 862.1660. FDA's definition for this code reads: "Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2009-01-15, and no recalls.

Classification record

Product code: OLD
Device name: Internal Polymerase Chain Reaction Control, Not Assay Specific
FDA definition: Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Regulation: 21 CFR 862.1660
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OLD

By decision year

1 clearance under product code OLD with a decision year between 2009 and 2009, 2009 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OLD by decision year
Year	Clearances
2009	1

Applicants with the most clearances

Product code OLD

Applicants holding the most 510(k) clearances under product code OLD
Applicant	Clearances
Nanogen, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OLD

K083430Class IReal-Time PCR Internal Control 2B SetNanogen, Inc. / cleared 2009-01-15

Recent recalls

Product code OLD

FDA records show no recalls under product code OLD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)