# K993787: Appraise-Cardio Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Group, Inc.
- Decided: Apr 14, 2000 after 157 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861697 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983172: Accu-Base Hemoglobin A1C Sample Collection Kit, Diabetes Technologies, Inc. (Dti) (1998) Summary page 1.

## Most influential descendants
- K021698: MY Allergy Test (2002), 0 descendants of its own

## Recalls of this device
- Jan 9, 2011 · Not classified · Z-0542-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0535-2012: Kits contain recalled Triad alcohol pads
- Jan 9, 2011 · Not classified · Z-0579-2012: Kits contain recalled Triad alcohol pads

## Indications for use
The Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician’s office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient’s total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.

Source page: https://510kreport.com/device/K993787
Methodology: https://510kreport.com/methodology