LogoFDA 510(k) Search
K Number
K981973
Device Name
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Manufacturer
RAM SCIENTIFIC
Date Cleared
1998-09-03

(90 days)

Product Code
JKA
Regulation Number
862.1675
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
K896206,K833475,K931368
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for testing.
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic hematology testing.

Device Description

The SAFE-T-FILL® Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. It is a non-invasive device. SAFE-T-FILL® is a 100 % plastic preassembled system made up of 4 components. A capillary end-to-end tube, a colored sleeve which holds the capillary, a microtube, and a cap. The sleeve and cap come in anticoagulant that is contained within the microtube. Blood is collected into the capillary tube and allowed to flow into the microtube. The tube is capped, mixed and then processed by the user organization.

AI/ML Overview

This 510(k) submission (K981973) for the SAFE-T-FILL® Capillary Blood Collection System is a premarket notification for a medical device seeking substantial equivalence to predicate devices, not a study presenting acceptance criteria and performance data for a new AI or diagnostic algorithm.

Therefore, the requested information cannot be extracted from the provided text, as it describes a product with a physical function (capillary blood collection) and seeks regulatory approval based on material and functional similarities to existing devices, not on diagnostic performance against specific criteria. There is no mention of an algorithm, AI, or diagnostic performance metrics typically associated with such studies.

Specifically:

  1. There is no table of acceptance criteria and reported device performance related to diagnostic accuracy because this is a physical blood collection device.
  2. No sample size for test sets or data provenance is mentioned as this is not a study evaluating diagnostic performance.
  3. No experts were used to establish ground truth because there is no diagnostic outcome to evaluate.
  4. No adjudication method is applicable.
  5. No MRMC comparative effectiveness study was done as there is no AI or diagnostic algorithm.
  6. No standalone performance study was done as there is no algorithm.
  7. No ground truth type is applicable.
  8. No sample size for the training set is applicable.
  9. No ground truth for the training set was established.

The document primarily focuses on:

  • Device Description: What the SAFE-T-FILL® system is and how it works.
  • Intended Use: For drawing capillary blood for testing.
  • Predicate Devices: Comparison to existing legally marketed devices (StatSampler®, CapiJect®, Microtainer®).
  • Substantial Equivalence: Arguing that the new device is as safe and effective as predicate devices based on design and function similarities.

The table in the document (page 1) lists characteristics of the SAFE-T-FILL® and predicate devices, which serve to demonstrate substantial equivalence, not diagnostic performance against acceptance criteria.

§ 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.