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.

Device Description

PerkinElmer 226 Sample Collection Device is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. The PerkinElmer 226 Sample Collection contains Ahlstrom 226 filter paper that is made from 100% pure cotton linters with no wet-strength additives added and conforms to the Recognized Standard CLSI LA4-A4. The Ahlstrom 226 filter paper has four performance characteristics that can be assessed with lysed or intact red blood cells; blood absorption time, blood spot diameter, serum absorption volume and homogeneity. Physical properties of the Ahlstrom 226 filter paper monitored during manufacturing are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.

AI/ML Overview

1. Table of acceptance criteria and reported device performance:

Performance Characteristic	Acceptance Criteria (from CLSI LA4-A4)	Reported Performance (PerkinElmer 226 Sample Collection Device)
Serum retention volume (1.8-inch paper punch)	1.37 - 1.71 µL	Ahlstrom paper lot 1: 1.477 µLAhlstrom paper lot 2: 1.443 µL
Homogeneity (spot-to-spot and sheet-to-sheet variability)	p-value > 0.05 (F-test for equivalence of mean values)	Ahlstrom paper lot 1: p=0.937Ahlstrom paper lot 2: p=0.607
Diameter of dried blood aliquot circle	15 - 17 mm (left to right and top to bottom)	Ahlstrom paper lot 1: 15.98 mmAhlstrom paper lot 2: 16.75 mm
Absorption time for 100 µL blood aliquot	5 - 30 seconds	Ahlstrom paper lot 2: 12.74 seconds (Lot 1 data missing from document)
Printing ink and printing process interference	No clinically significant interference	No clinically significant interference observed with analytic test procedures of four representative newborn screening assays and with spiked samples for specific kits.
Clinical performance (relative to predicate)	Non-significant clinical difference in population median values of 2-10% for all 12 analytes tested.	Achieved: "non-significant clinical difference in population median values of 2-10% for all 12 analytes tested."

2. Sample size used for the test set and data provenance:

Physical Properties (Absorption capacity, homogeneity, diameter, absorption time): The exact sample size for each physical test (e.g., number of punches, number of blood aliquots) is not explicitly stated. The tests were performed on "Ahlstrom paper lot 1" and "Ahlstrom paper lot 2." The provenance is internal testing by the manufacturer or an associated entity (Ahlstrom).
Clinical Performance (Comparison to predicate):
- Sample Size: N=2000 per device type (meaning 2000 samples collected with the PerkinElmer 226 and presumably 2000 with the Whatman 903 for comparison, though this is implied rather than explicitly stated as a direct paired comparison).
- Data Provenance: Retrospective data provided by a U.S. newborn screening laboratory. The data was gathered "during the process of transitioning from the Whatman 903 Specimen Collection Paper to the PerkinElmer 226 Sample Collection Device."

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This device is a sample collection medium, not an AI or diagnostic device that requires expert interpretation for ground truth establishment. The "ground truth" for its performance is based on established physical properties and analytical performance without human subjective assessment.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The device's performance is assessed based on objective physical measurements and analytical results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device for blood specimen collection, not an AI system or diagnostic tool requiring human reader involvement for performance assessment in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical sample collection device, not an algorithm.

7. The type of ground truth used:

Physical Properties: The ground truth for the physical properties (absorption capacity, homogeneity, diameter, absorption time) is based on quantitative measurements against the pre-defined ranges and statistical criteria specified in the CLSI LA4-A4 standard.
Clinical Performance: The "ground truth" for clinical performance was based on the analytical results of specific newborn screening assays (NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry test system, AutoDELFIA 17OHP, IRT and T4 kits, Neonatal GALT kit, Neonatal Biotinidase kit, Hemoglobinopathy data) from a U.S. newborn screening laboratory, compared between the new device and the predicate. The outcome was the measured concentration/value of the analytes.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The Assigned 510(k) Number is: K121864

Date: March 8, 2013

Submitted by:	PerkinElmer Health Sciences17 P&N DriveGreenville, SC 29611
Contact Person:	Kay A. TaylorTel: 317-418-1735Fax: 317-536-3064
Trade Name:	PerkinElmer 226 Sample Collection Device
Common Name:	Blood Specimen Collection Device
Regulation:	21 CFR 862.1675
Classification Name:	tubes, vials, systems, serum separators, blood collection
Product Code:	JKA
Predicate Device(s):	Ahlstrom 226 Specimen Collection Paper - K062932Whatman 903 Specimen Collection Paper - pre-amendmentdevice
Device Description:	PerkinElmer 226 Sample Collection Device is designed toprovide a uniform surface for the collection of blood spots.A drop of blood is applied to the filter paper and allowed tosoak through the paper. The sample is then air dried andsent to a laboratory for further analysis.The PerkinElmer 226 Sample Collection contains Ahlstrom226 filter paper that is made from 100% pure cotton linterswith no wet-strength additives added and conforms to theRecognized Standard CLSI LA4-A4. The Ahlstrom 226filter paper has four performance characteristics that can beassessed with lysed or intact red blood cells; bloodabsorption time, blood spot diameter, serum absorptionvolume and homogeneity. Physical properties of theAhlstrom 226 filter paper monitored during manufacturing

{1}------------------------------------------------

are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.

When used in newborn screening, the PerkinElmer 226 Sample Collection Device demographic form should contain (at a minimum) the following information.

Infant's name [last (and first available)] ●
Mother's first and last name .
Gender .
Birth date (optional: include time of birth) ●
Date of specimen collection .
Infant's age (indicate if less than 24 hours; optional: . include address and phone number)
Patient ID number (e.g., medical record number; optional: include address and phone number)
. Birth weight
. Submitter's ID and address (optional: include birth facility)
Physician's name (healthcare provider) . and telephone number
Name of newborn screening program and address .
Unique non-repeating serial number .
. Expiration date of specimen collection device
Appropriate number of preprinted circles ●
Manufacturer and lot number of the filter paper ●
Manufacturer or printer of the Sample Collection . Device

The Ahlstrom 226 filter paper component is supplied to PerkinElmer Health Sciences where production of the final device which involves printing on the filter paper, affixing the filter paper to the carrier device to provide rigidity and, if required, affixing a tear-apart form for the collection of demographic information is performed. Depending on the end users requirements the final device may be only the printed filter paper with carrier device or printed filter paper with carrier device and demographic form which may be comprised of multiple sheets.

{2}------------------------------------------------

Intended Use:

Substantial Equivalence:

The PerkinElmer 226 Sample Collection Device is substantially equivalent to Ahlstrom 226 Specimen Collection Paper (K062932) device. The follow table provides a summary of device comparison.

Characteristic	PerkinElmer 226(New Device)	Ahlstrom 226(Predicate Device)
Intended Use	The PerkinElmer 226 SampleCollection Devices are intended tobe used as a medium to collect andtransport whole blood specimenspots to a laboratory, in newbornscreening. The device includes atear-apart form for the collectionof demographic information.	The Ahlstrom 226 specimencollection paper is intended to beused as a medium to collect andtransport blood specimen spotsto a laboratory. The collectionpaper is in the format of aprinted card that may beincorporated along with a tear-apart form for the collection ofdemographic information
Description	Various sizes of Ahlstrom 226filter paper, printed and affixed toa carrier such as cardboard orplastic; and may be incorporatedalong with a tear-apart form	Same
Matrix	Whole blood	Same
Storage conditionsfor unused cards	Store in a cool dry space awayfrom direct sunlight.	Same
Specimen dryingtime	3 - 4 hours	Same
Standard referenced	CLSI LA4 - A4: Blood Collection onFilter Paper for Newborn ScreeningPrograms	Same

Device Similarities and Differences

Performance Characteristics:

The FDA recognized consensus standard for the device is the CLSI LA4-A4: Blood Collection on Filter Paper for Newborn Screening Program; Approved Standard. The standard describes four physical properties of the filter paper and acceptance criteria for each. Additionally the CLSI LA4-A4 requires the printing ink and printing process must

{3}------------------------------------------------

not interfere with the analytic test procedure. The PerkinElmer 226 Sample Collection device meets the requirements specified in the CLSI standard.

Physical Properties:

Absorption capacity as measured by serum retention volume of a 1.8 inch paper l. punch taken from a dried blood spot. A range of 1.37 - 1.71 µL is considered acceptable.

Ahlstrom paper lot 1 (mean)	1.477 µL
Ahlstrom paper lot 2 (mean)	1.443 µL

1. Homogeneity of the filter paper lot (spot-to-spot and sheet-to-sheet variability). To perform this test, blood samples tagged with 1751 labelled T4 are applied to the filter paper. Samples (punches) of the filter paper are removed from pre-defined areas within the same lot and between lots. By measuring the amount of 1351 labelled T4, the homogeneity of the lot is calculated using a hierarchical, nested analysis of variance technique. An F-test is used to test equivalence of the mean values of the lots of paper. A p value of greater than 0.05 is considered acceptable.

Ahlstrom paper lot 1	p=0.937
Ahlstrom paper lot 2	p=0.607

1. Diameter of the circle for the dried blood aliquot. A range of 15-17 mm left to right and top to bottom is considered acceptable.

Ahlstrom paper lot 1 (mean)	15.98 mm
Ahlstrom paper lot 2 (mean)	16.75 mm

1. Absorption time for a 100 µL blood aliquot. A range of 5 30 seconds is considered acceptable.

Ahlstrom paper lot 1 (mean)
Ahlstrom paper lot 2 (mean)	12.74 seconds

1. Printing ink and printing process: No clinically significant interference was observed with the analytic test procedure of four representative newborn screening assays incorporating immunometric, competitive and enzymatic methodologies.

Assay Performance:

The population data (N=2000/device type) provided by a U.S. newborn screening laboratory during the process of transitioning from the Whatman 903 Specimen Collection Paper to the PerkinElmer 226 Sample Collection Device was analyzed. The analysis showed a non-significant clinical difference in population median values of 2-

{4}------------------------------------------------

10% for all 12 analytes tested. The products tested included NeoGram Amino Acids and Acvicamitines Tandem Mass Spectrometry test system, AutoDELFIA 17OHP, IRT and T4 kits, Neonatal GALT kit, and Neonatal Biotinidase kit. Hemoglobinopathy data acquired with the Bio-Rad VARIANTnbs Newborn Screening System as showed similar frequency results within the same population.

Based on test results for the GSP Neonatal hTSH and 170HP kits, the AutoDELFIA Neonatal T4 kit and the Neonatal Total Galactose kit with spiked samples; no interference from the printing ink or printing process was observed.

Conclusion:

The information provided in this premarket notification demonstrates that the PerkinElmer Sample Collection Device is substantially equivalent to the predicate devices; and satisfies the requirements of CLSI LA4-A4.

l I

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered horizontally. To the left of the text is a logo of the Department of Health and Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

PerkinElmer, Inc. C/o Kay Taylor VP, Global Regulatory, Quality, and Clinical Affairs 17 P&N Drive Greenville, SC 29611

FEB 0 6 2015

Re: K121864

Trade/Device Name: PerkinElmer 226 Sample Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: PJC Dated: February 13, 2013 Received: February 19, 2013

Dear Ms. Taylor:

This letter corrects our substantially equivalent letter of March 12, 2013.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor 31 ttps://pedia.net/ally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosal of the enactment date of the Medical Device Amendments or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug. devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (710c) that to not requestly controls provisions of the Act. The r ou may, mercere, mainer of the Act include requirements for annual registration, listing of general oontrols provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Tease note: 02121 accs that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (600 ace re) insting major regulations affecting your device can be may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advisou that I Dr o losean that your device complies with other requirements of the Act that I Dri has mad regulations administered by other Federal agencies. You must or any I cuttar surates and regaranents, including, but not limited to: registration and listing (21

{6}------------------------------------------------

Page 2 - Dear Ms. Taylor

CFR Part 807); labeling (21 CFR Parts 801 and 809; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

C. Kee Osum

Courtney H. Lias, Ph.D. DIRECTOR Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K121864

Device Name: PerkinElmer 226 Sample Collection Device

Indications for Use:

The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect I the I cranibilities 220 balliple constitution to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Prescription Use XXXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

and the commended to the country of

. |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung WD Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K121864 510(k)

Page 1 of 1

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.