CUSTOMED BLOOD EXTRACTION KIT

K962596 · Customed, Inc. · GJE · Sep 27, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962596
• Device Name: CUSTOMED BLOOD EXTRACTION KIT
• Applicant: Customed, Inc.
• Product Code: GJE · Clinical Chemistry
• Decision Date: Sep 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.

Device Story

Customed Blood Collection Kit; assembly of disposable, single-use medical products within a pouch. Kit contents include skin preparation materials, blood collection tubes, needles, and site dressing materials. Used by healthcare professionals in clinical settings for venous blood specimen collection. Provides convenience by consolidating legally marketed, exempt, or grandfathered components into a single tray. Output is a collected blood specimen for diagnostic testing. No new uses claimed.

Clinical Evidence

No clinical evaluations were completed.

Technological Characteristics

Kit assembly of disposable, single-use medical devices. Components include skin prep, needles, collection tubes, and dressings. No specific materials, energy sources, or software described.

Indications for Use

Indicated for healthcare professionals performing venous blood specimen collection and transport for in-vitro diagnostic use.

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

• Angiosystems, Inc. blood collection kits (K905464/A)

Submission Summary (Full Text)

{0}

mdi
K962596
EXHIBIT 1

510(K) Summary
Customed
Blood Collection Kit
SEP 27 1996

## Submitter Information

Customed
Calle Igualdad #7
Prjardo, PR 00738
Tel: [phone]

## 510(K) Summary Prepared By:

Carolann Kotula
mdi Consultants, Inc.
55 Northern Blvd.
Great Neck, NY 11021
Tel: [phone]

## Date 510(K) Summary Prepared: August 15, 1996

## Trade or Proprietary Name: Customed Blood Collection Kit

## Common Name: Venous Blood Specimen Collection Kit

## Classification Name: Blood Specimen Collection devices, 21 CFR 862.1675

## Identification of Legally Marketed Device to which the Submitter Claims Equivalence:

The Customed Blood Extraction kit is substantially equivalent in intended use, and kit contents as various blood collection kits legally marketed by Angiosystems, Inc. under K905464/A.

## Description of the Subjected Devices:

The Customed Blood Collection Kits are an assembly of medical products within a pouch. The medical products are disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the kit are commonly used for blood specimen collection and Customed is not claiming or causing new uses through the intended use of the kit.

Consulting since 1978

{1}

mdi
EXHIBIT 1

# 510(K) Summary
## Customed
## Blood Collection Kit

### Intended Use of the Subject Devices

The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.

### Technical Characteristics of the Subject Device

The technological characteristics of the Customed Blood Collection kit and the predicate device are substantially equivalent as supported by the comparison of similar significant features, components, and intended use.

No clinical evaluations were completed.

Consulting since 1978