(259 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance characteristics of the filter paper for blood collection, with no mention of AI or ML.
No.
The device is described as a collection and transport medium for whole blood specimens, not for treating or diagnosing a disease or condition.
No
The device is a sample collection and transport medium, designed to prepare samples for analysis, not to perform the analysis itself. The analysis ("further analysis") is done at a laboratory, which suggests the device itself does not diagnose.
No
The device is a physical sample collection device made of filter paper, not software.
Based on the provided information, the PerkinElmer 226 Sample Collection Device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "collect and transport whole blood specimen spots to a laboratory, in newborn screening." This is a crucial step in the process of performing diagnostic tests on biological samples in vitro (outside the body).
- Function: The device provides a medium (filter paper) for collecting and preserving a biological sample (blood) for subsequent laboratory analysis. This is a fundamental function of many IVD devices, particularly those used for sample collection and preparation.
- Context: The device is intended for use in "newborn screening," which is a well-established area of IVD testing aimed at identifying potential health issues in newborns.
- Predicate Devices: The listed predicate devices (Ahlstrom 226 Specimen Collection Paper and Whatman 903 Specimen Collection Paper) are also sample collection devices used in laboratory testing, further supporting the classification as an IVD.
While the device itself doesn't perform the diagnostic test, it is an essential component of the overall in vitro diagnostic process by providing the means to collect and transport the sample that will be analyzed.
N/A
Intended Use / 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.
Product codes
JKA, PJC
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborn
Intended User / Care Setting
Laboratory / newborn screening
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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: Measured by serum retention volume of a 1.8 inch paper l. punch taken from a dried blood spot. Acceptable range: 1.37 - 1.71 µL.
- Ahlstrom paper lot 1 (mean): 1.477 µL
- Ahlstrom paper lot 2 (mean): 1.443 µL
- Homogeneity: Measured by lot (spot-to-spot and sheet-to-sheet variability) using blood samples tagged with 1751 labelled T4. An F-test is used for equivalence with a p-value > 0.05 being acceptable.
- Ahlstrom paper lot 1: p=0.937
- Ahlstrom paper lot 2: p=0.607
- Diameter of dried blood aliquot circle: Acceptable range: 15-17 mm left to right and top to bottom.
- Ahlstrom paper lot 1 (mean): 15.98 mm
- Ahlstrom paper lot 2 (mean): 16.75 mm
- Absorption time for 100 µL blood aliquot: Acceptable range: 5-30 seconds.
- Ahlstrom paper lot 2 (mean): 12.74 seconds
- Printing ink and printing process: No clinically significant interference observed with analytic test procedure of four representative newborn screening assays.
Assay Performance:
- Population data (N=2000/device type) from a U.S. newborn screening laboratory showed a non-significant clinical difference in population median values of 2-10% for all 12 analytes tested. Products included NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry test system, AutoDELFIA 17OHP, IRT and T4 kits, Neonatal GALT kit, and Neonatal Biotinidase kit.
- Hemoglobinopathy data (Bio-Rad VARIANTnbs Newborn Screening System) showed similar frequency results within the same population.
- No interference from printing ink or process observed when tested with GSP Neonatal hTSH and 17OHP kits, AutoDELFIA Neonatal T4 kit and Neonatal Total Galactose kit with spiked samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ahlstrom 226 Specimen Collection Paper - K062932, Whatman 903 Specimen Collection Paper - pre-amendment device
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Sciences
17 P&N Drive
Greenville, SC 29611 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kay A. Taylor
Tel: 317-418-1735
Fax: 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 - K062932
Whatman 903 Specimen Collection Paper - pre-amendment
device |
| 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 |
7
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.
8
2
Intended 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.
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 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. | The Ahlstrom 226 specimen
collection paper is intended to be
used as a medium to collect and
transport blood specimen spots
to a laboratory. The collection
paper is in the format of a
printed card that may be
incorporated along with a tear-
apart form for the collection of
demographic information |
| Description | Various sizes of Ahlstrom 226
filter paper, printed and affixed to
a carrier such as cardboard or
plastic; and may be incorporated
along with a tear-apart form | Same |
| Matrix | Whole blood | Same |
| Storage conditions
for unused cards | Store in a cool dry space away
from direct sunlight. | Same |
| Specimen drying
time | 3 - 4 hours | Same |
| Standard referenced | CLSI LA4 - A4: Blood Collection on
Filter Paper for Newborn Screening
Programs | 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 |
-
- 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 |
-
- 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 |
-
- 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 |
-
- 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-
10
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)
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