# K121864: Perkinelmer 226 Sample Collection Devices

- Pathway: 510(k) (Abbreviated)
- Applicant: Perkinelmer, Inc.
- Decided: Mar 12, 2013 after 259 days
- Product code: PJC (Newborn Screening Specimen Collection Paper)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932661 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062932: Ahlstrom Grade 226 Specimen Collection Paper, Ahlstrom Mount Holly Springs, LLC (2007) Summary page 1.
- (no number) Whatman 903 Specimen Collection Paper: named in the summary without a submission number

## Recalls of this device
- Dec 19, 2017 · Class III · Z-2264-2020: PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
- May 31, 2017 · Class III · Z-2756-2017: PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
- Sep 5, 2013 · Class II · Z-0030-2014: Some devices may be contaminated on the back side of the device with glue in the blood application area.

## Indications for use
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Source page: https://510kreport.com/device/K121864
Methodology: https://510kreport.com/methodology