← Product Code [GGC](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC) · K032804

# CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804)

_Precision Biologic · GGC · Nov 3, 2003 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K032804

## Device Facts

- **Applicant:** Precision Biologic
- **Product Code:** [GGC](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC.md)
- **Decision Date:** Nov 3, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

CryoCheck Weak Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.

## Device Story

CryoCheck Weak Positive Control; human source plasma-derived control; frozen format. Used in clinical laboratory settings to verify performance of lupus anticoagulant assays. Provides weak positive signal to monitor assay sensitivity; ensures quality control for coagulation testing. Clinicians/technicians use output to validate assay results; ensures accurate detection of lupus anticoagulant in patient samples.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Human source plasma; frozen liquid control; standalone diagnostic reagent. No software or electronic components.

## Regulatory Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Predicate Devices

- CryoCheck Positive Control ([K952623](/device/K952623.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032804

B. Analyte:
Lupus

C. Type of Test:
Control

D. Applicant:
Precision BioLogic

E. Proprietary and Established Names:
CryoCheck Weak Positive Control

F. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
2. Classification:
Class II
3. Product Code:
GGC
4. Panel:
81 Hematology

G. Intended Use:
1. Indication(s) for use:
CryoCheck Weak Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
2. Special condition for use statement(s):
3. Special instrument Requirements:

H. Device Description:

I. Substantial Equivalence Information:
1. Predicate device name(s):
CryoCheck Positive Control
2. Predicate K number(s):
K952623

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3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Material | Human source | Same  |
|  Intended Use | Use as a positive control in assays for lupus anticoagulant | Same  |
|  Format | Frozen | Same  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Potency | Weak Positive | Strong Positive  |

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

K. Test Principle:

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Intra-Vial Precision (%CV)
PT - 0.55%    APTT - 0.62%
b. Linearity/assay reportable range:
c. Traceability (controls, calibrators, or method):
d. Detection limit:
e. Analytical specificity:
f. Assay cut-off:

2. Comparison studies:
a. Method comparison with predicate device:
b. Matrix comparison:

3. Clinical studies:
a. Clinical sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:

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5. Expected values/Reference range:

M. Conclusion:
Based on a review of the precision data, and device labeling I recommended that this device is found substantially equivalent to a legally marketed device.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K032804](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGC/K032804)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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