Cleared Traditional

K234088 - Emily's Care Nourish Test System (Model 1) (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234088 · Lactation Lab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
133d
Days
Class 2
Risk

K234088 is an FDA 510(k) clearance for the Emily's Care Nourish Test System (Model 1). Classified as Breast Milk Macronutrients Test System (product code QEI), Class II - Special Controls.

Submitted by Lactation Lab, Inc. (Manhattan Beach, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1493 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lactation Lab, Inc. devices

Submission Details

510(k) Number K234088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date May 03, 2024
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEI Breast Milk Macronutrients Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1493
Definition A Breast Milk Macronutrient Test System Is A Device Intended To Quantitatively Measure Fat, Protein, And Total Carbohydrate Content In Human Breast Milk. These Measurements, In Conjunction With Other Clinical Assessments, May Be Used To Aid In The Nutritional Management Of Infants.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.