AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER

K062932 · Ahlstrom Mount Holly Springs, LLC · JKA · Oct 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062932
• Device Name: AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
• Applicant: Ahlstrom Mount Holly Springs, LLC
• Product Code: JKA · Clinical Chemistry
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

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 226 paper will be in the format of a printed card that may be incorporated along with a tear-apart form for demographic information.

Device Story

Ahlstrom 226 specimen collection paper provides a uniform surface for collecting blood spots. A drop of blood is applied to the filter paper, allowed to soak through, and air-dried. The dried sample is transported to a laboratory for analysis. The device consists of 100% pure cotton linter paper, often integrated into a printed card with a tear-apart form for demographic data. It is used by healthcare providers in clinical settings to facilitate newborn screening or other blood-based diagnostic testing. The paper's physical properties—absorption time, spot diameter, serum absorption volume, and homogeneity—ensure consistent sample quality for laboratory processing. By providing a standardized collection medium, the device enables reliable transport of blood specimens, supporting accurate clinical decision-making based on the subsequent laboratory analysis.

Clinical Evidence

Bench testing only. Samples from three lots were evaluated by the CDC Newborn Screening Quality Assurance Program using NCCLS LA4-A3 standards for lysed and intact red blood cells. Parameters tested (absorption time, spot diameter, serum absorption volume, homogeneity) were within acceptable limits. Independent laboratory testing confirmed consistency across lots and comparability to CDC results. No clinical human trials were conducted.

Technological Characteristics

Material: 100% pure cotton linters; no wet-strength additives. Basis weight: 110 lb +/- 5% (ASTM D646-96). pH: 5.7 to 7.5 (ISO 6599:1981). Ash: 0.1% max (ASTM D586-97a). Form factor: Printed card with filter paper section. Performance standards: NCCLS LA4-A3.

Indications for Use

Indicated for the collection and transport of whole blood specimens for laboratory analysis. No specific patient population or contraindications defined.

Regulatory Classification

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.

Predicate Devices

• Whatman Body Fluid Collection Paper: Whatman BFC 18 (K932661)

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k062932

B. Purpose for Submission:
New device

C. Measurand:
Not applicable (device is intended to be used to collect whole blood)

D. Type of Test:
Not applicable

E. Applicant:
Ahlstrom Filtration LLC

F. Proprietary and Established Names:
Ahlstrom 226 Specimen Collection Paper

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1675
2. Classification:
Class II
3. Product code:
JKA
4. Panel:
75 (Clinical Chemistry)

H. Intended Use:
1. Intended use(s):
Ahlstrom 226 specimen collection paper is intended to be used as a medium to collect and transport blood specimen spots to a laboratory. The 226 paper will be in the format of a printed card that may be incorporated along with a tear-apart form for demographic information.
2. Indication(s) for use:
Refer to Intended Use above.
3. Special conditions for use statement(s):

{1}

Prescription use only.

4. Special instrument requirements:
Not applicable.

I. Device Description:

Ahlstrom 226 Specimen Collection Paper is made from 100% pure cotton linters and provides 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 analysis.

J. Substantial Equivalence Information:

1. Predicate device name:
Whatman Body Fluid Collection Paper

2. Predicate K number(s):
k932661

3. Comparison with predicate:
| Item | Device | Predicate |
| --- | --- | --- |
| Intended Use | Intended to be used as a medium to collect and transport blood specimen spots to a laboratory for further testing | 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 | 3 hours minimum |
| Standard referenced | NCCLS/CLSI LA4 – A3: Blood Collection on Filter Paper for Newborn Screening Programs | Same |

{2}

K. Standard/Guidance Document Referenced (if applicable):

NCCLS/CLSI LA4-A3: Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Third Edition

L. Test Principle:

Not applicable (device may be used to collect whole blood).

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Not applicable
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable. This device is intended for the collection of whole blood only.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
The FDA recognized consensus standard for this device is NCCLS/CLSI LA4-A3: Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Third Edition. This standard describes four physical

{3}

properties of the filter paper and acceptance criteria for each:

1. Absorption capacity as measured by serum retention volume of a 1/8 inch paper punch taken from a dried blood spot. A range of 1.37 – 1.71 µL is considered acceptable.

Ahlstrom Lot 1 mean 1.477 µL

Ahlstrom Lot 2 mean 1.443 µL

2. Homogeneity of the filter paper lot (spot-to-spot and sheet-to-sheet variability). To perform this test, blood samples tagged with $^{125}\mathrm{I}$ labeled 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 $^{125}\mathrm{I}$ labeled 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 Lot 1 p = 0.937

Ahlstrom Lot 2 p = 0.607

3. 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 Lot 1 mean 15.98 mm

Ahlstrom Lot 2 mean 16.75 mm

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

Ahlstrom Lot 1 mean 7.88 seconds

Ahlstrom Lot 2 mean 12.74 seconds

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.